A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

开始日期2027-09-09

申办/合作机构

Northwestern University

[+1]

NCT07763171

/ Not yet recruiting临床3期IIT

Paclitaxel Plus Ramucirumab and Tislelizumab as Switch Maintenance Versus Continuation of Chemotherapy and Tislelizumab in Patients With Advanced HER2-negative and PD-L1 Positive Gastroesophageal Adenocarcinoma: the ARMANI-2/ENGIC08 Trial by GONO

ARMANI-2/ENGIC8 is a randomized, open-label, phase III trial evaluating a switch maintenance strategy in patients with previously untreated, locally advanced unresectable or metastatic, HER2-negative and PD-L1-positive gastroesophageal adenocarcinoma.
The combination of platinum- and fluoropyrimidine-based chemotherapy with an anti-PD-1 agent represents a first-line treatment option for patients with advanced HER2-negative, PD-L1-positive gastroesophageal adenocarcinoma. However, disease progression remains frequent and may lead to clinical deterioration, preventing a substantial proportion of patients from receiving subsequent anticancer treatment.
The phase III ARMANI trial demonstrated that, in patients with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma who achieved disease control after 3 months of first-line oxaliplatin- and fluoropyrimidine-based chemotherapy, switching to paclitaxel plus ramucirumab significantly improved progression-free survival and overall survival compared with continuation of the initial chemotherapy. These findings support the early introduction of a non-cross-resistant treatment before the development of chemotherapy-resistant disease and clinical deterioration.
ARMANI-2 builds on this strategy in the current immunotherapy-based treatment setting. In addition, VEGF/VEGFR blockade may have immunomodulatory effects that provide a biological rationale for combining ramucirumab with PD-1 blockade.
All eligible patients will receive a 12-week induction treatment with tislelizumab combined with platinum- and fluoropyrimidine-based chemotherapy (mFOLFOX6, CAPOX, or cisplatin plus fluorouracil). Patients who complete induction without disease progression or permanent treatment discontinuation will be randomized 1:1 to receive either switch maintenance with paclitaxel, ramucirumab, and tislelizumab (Arm A) or continuation of the chemotherapy regimen used during induction in combination with tislelizumab (Arm B).
The primary objective is to determine whether switch maintenance with paclitaxel, ramucirumab, and tislelizumab improves progression-free survival compared with continuation of chemotherapy and tislelizumab. Secondary objectives include overall survival, PFS2, tumor response and disease control, safety, health-related quality of life, and attrition to subsequent anticancer therapy. Exploratory analyses will investigate clinical and translational biomarkers potentially associated with treatment efficacy and early disease progression.

开始日期2026-09-01

申办/合作机构

Gruppo Oncologico del Nord-Ovest

NCT07546812

/ Recruiting临床2期

A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and/or Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas

The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and/or metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas.
The primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).

开始日期2026-08-07

申办/合作机构

Gilead Sciences, Inc.

100 项与雷莫西尤单抗相关的临床结果

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100 项与雷莫西尤单抗相关的转化医学

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100 项与雷莫西尤单抗相关的专利（医药）

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1,209

项与雷莫西尤单抗相关的文献（医药）

2026-12-01·ESMO Gastrointestinal Oncology

Randomized phase II trial of zolbetuximab as second-line treatment in patients with claudin 18.2-positive advanced gastric/GEJ cancer with previous zolbetuximab exposure: ZELDA

Article

作者: Hirano, H ; Esaki, T ; Oki, E ; Furuta, M ; Murotani, K ; Narita, Y ; Muro, K ; Ando, K ; Kawakami, H ; Inagaki, C

Background:

Zolbetuximab, an anti-claudin 18.2 (CLDN18.2) monoclonal antibody, combined with fluoropyrimidine- and platinum-based chemotherapy, is established as first-line standard of care for patients with CLDN18.2-positive, human epidermal growth factor receptor 2-negative advanced gastric or gastroesophageal junction (GEJ) cancer, based on the phase III SPOTLIGHT and GLOW trials. However, evidence regarding the efficacy and safety of continuing zolbetuximab beyond disease progression remains lacking. Given reports that CLDN18.2 expression is maintained after chemotherapy and the absence of clearly established resistance pathways, continued CLDN18.2-targeted therapy in the second-line setting warrants investigation.

Aim:

To investigate whether the addition of zolbetuximab to second-line nab-paclitaxel plus ramucirumab improves overall survival (OS) in patients with CLDN18.2-positive advanced gastric or GEJ adenocarcinoma who have progressed with first-line zolbetuximab-based therapy.

Trial design:

ZELDA (jRCTs071250038) is a multicenter, open-label, randomized phase II (rP2) trial conducted by the West Japan Oncology Group and Kyushu Study Group of Clinical Cancer in Japan. A safety lead-in part (n = 6) confirms the tolerability of the triplet combination (zolbetuximab + nab-paclitaxel + ramucirumab), followed by a rP2 trial (n = 210) with a 1 : 1 allocation to nab-paclitaxel + ramucirumab (arm A, control) or zolbetuximab + nab-paclitaxel + ramucirumab (arm B, experimental). The primary endpoint is OS in the full analysis set. Integrated translational research (ZELDA-TR) is also planned.

2026-11-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Comment on “Theranostic potential of ramucirumab functionalized magnetoliposomes for targeted delivery of sorafenib and MRI”

Letter

作者: Gite, Kuldip V ; Akotkar, Akshay ; Bhise, Manish R ; Bhandari, Shweta

2026-10-01·INTERNATIONAL JOURNAL OF CANCER

Plasma PlGF as a Potential Biomarker in Ramucirumab‐Based Second‐Line Therapy for Advanced Gastroesophageal Adenocarcinoma: Exploratory Biomarker Analysis from the Phase II Part of the RAMIRIS Trial

Article

作者: Sonja Loges ; Stefan Probst ; Sylvie Lorenzen ; Melanie Janning ; Victoria Gensch ; Peter Reichardt ; Peter Thuss-Patience ; Christian Müller ; Claudia Pauligk ; Jurek Hille ; Florian Lordick ; Thorsten O. Goetze ; Carsten Bokemeyer ; Martin Sökler ; Eray Goekkurt ; Salah E. Al-Batran ; Thomas Ettrich ; Daniel Pink

ABSTRACT:

Antiangiogenic treatment with ramucirumab (RAM) is a standard second‐line option in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma. However, reliable biomarkers are lacking. The phase II RAMIRIS trial compared RAM plus paclitaxel with RAM plus FOLFIRI (5‐fluororuracil, leucovorin and irinotecan) in this setting. We present the exploratory biomarker analysis evaluating placental growth factor (PlGF), carbonic anhydrase IX (CAIX), and tryptase. Plasma samples from 99 patients enrolled in RAMIRIS were collected at predefined timepoints (baseline, Cycle 2 Day 1, and Cycle 4 Day 1). PlGF, CAIX, and tryptase were quantified by ELISA. Associations with progression‐free survival (PFS) and overall survival (OS) were analyzed using dichotomized biomarker levels and Cox regression models. PlGF levels increased substantially under treatment, whereas CAIX showed a transient rise, followed by a slight decline, and tryptase remained stable. Elevated PlGF levels at baseline and early‐treatment (c2d1) were associated with shorter OS in univariate analysis (baseline HR u = 1.75; p = 0.020; c2d1 HR u = 1.69; p = 0.054). After multivariate adjustment, the association remained directionally consistent; although statistical support was retained only for c2d1 (baseline HR m = 1.41, p = 0.198; c2d1 HR m = 1.85, p = 0.030). CAIX and tryptase showed no consistent associations with survival. Elevated PlGF—particularly its early increase during RAM‐based therapy—was associated with shortened survival and may represent a dynamic marker of unfavorable prognosis in advanced gastric/GEJ adenocarcinoma. Given the exploratory nature of this analysis, these findings should be considered hypothesis‐generating and require validation in independent biomarker‐driven studies.

1,541

项与雷莫西尤单抗相关的新闻（医药）

2026-10-22

·BioSpace

Daiichi Sankyo Highlights Ongoing Progress Across Industry-Leading ADC Portfolio with New Research Updates at ESMO

New data from six landmark trials reinforce practice-changing results of Enhertu and Datroway across a broad spectrum of patients in breast and lung cancer Additional analyses from two trials of raludotatug deruxtecan in ovarian cancer demonstrate emerging potential in gynecological cancers TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 30 abstracts, including four late breaking presentations, in multiple cancers at the 2026 European Society for Medical Oncology (#ESMO26) Congress. New data from six landmark trials demonstrate the company’s progress toward advancing new standards of care for patients in breast and lung cancer, including the DESTINY-Breast05 ( 539RO ), DESTINY-Breast06 ( 4279P ), DESTINY-Breast09 ( LBA49 ), DESTINY-Breast11 ( 543RO ) and DESTINY-Lung04 ( LBA74 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan) and the TROPION-Breast02 ( LBA96 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional data at ESMO also will spotlight the company’s commitment to advancing research for patients with advanced ovarian cancer across lines of therapy. An updated analysis, including progression-free survival and duration of response, will be presented from the REJOICE-Ovarian01 ( 1331P ) phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. A mini oral presentation will highlight preliminary findings from the REJOICE-Ovarian02 ( 1247RO ) phase 1b/2 trial evaluating raludotatug deruxtecan in combination with bevacizumab in patients with platinum-resistant ovarian cancer. “The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo continues to draw from its scientific and technological expertise to turn science into new medicines that can change the standard of care.” Data Demonstrate Benefit of DXd ADCs in Patients with Brain Metastases Research updates highlighting the impact of DXd ADCs in patients with brain metastases include late-breaking rapid oral and proffered paper presentations from the DESTINY-Breast09 ( LBA49 ) phase 3 trial evaluating Enhertu in combination with pertuzumab as a first-line treatment for patients with HER2 positive metastatic breast cancer and the TROPION-Breast02 ( LBA96 ) phase 3 trial evaluating Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option. Final overall survival results of the TUXEDO-3 ( 690O ) phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases from metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) or leptomeningeal disease from any solid tumor will be presented as a proffered paper. New Data and Trials-in-Progress Presentations Across DXd ADC Portfolio Additional data highlighting new research across the DXd ADC portfolio include oral and poster presentations, including final results of the TALENT ( LBA23 ) phase 2 trial of Enhertu alone or in combination with anastrozole, or in sequence with chemotherapy, as neoadjuvant treatment for patients with HR positive, HER2 low early stage breast cancer. New data in NSCLC include the NeoCOAST-2 ( 4244RO ) phase 2 trial reporting event-free survival results, as well as findings on the association of ctDNA clearance with clinical outcomes in patients with resectable, early stage NSCLC treated with a combination of Datroway plus durvalumab and chemotherapy, and a retrospective analysis evaluating mechanisms of insensitivity to the Datroway payload in subgroups of patients with advanced NSCLC in the TROPION-Lung01 ( 4451P ) phase 3 trial. Updated findings from the EPOC2003 ( 2888P ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer: results from ESPERANZA ( 1014P ), an external comparator study evaluating Enhertu versus real-world standard of care as a second line or later treatment for patients with HER2 IHC 3+ solid tumors; and, the primary analysis evaluating patritumab deruxtecan monotherapy in patients with melanoma in the HERTHENA-PanTumor01 ( 2073RO ) phase 2 trial also will be presented. Trials-in-progress poster presentations include the DESTINY-Breast Guide ( 1795TiP ) prospective and interventional trial evaluating first-line treatment with Enhertu plus pertuzumab followed by palbociclib, endocrine therapy and dual HER2 blockade (trastuzumab plus pertuzumab), as well as retreatment with Enhertu following progression on maintenance therapy (palbociclib, endocrine therapy and trastuzumab plus pertuzumab) in previously untreated patients with HER2 positive advanced or metastatic breast cancer and the TROY ( 1335TiP ) phase 2 trial evaluating Enhertu in patients with recurrent ovarian cancer with disease progression on prior PARP inhibitor therapy. An overview of late-breaking, clinical data and trials-in-progress presentations from the ADC portfolio of Daiichi Sankyo includes: Presentation Title Author Abstract Presentation (CEST) LBAs Final results of TALENT: a neoadjuvant trial of T-DXd with or without anastrozole, or in sequence with chemotherapy for HER2-low, HR+ early-stage breast cancer S. Hurvitz LBA23 Proffered Paper Presentation Friday, October 23 1:30 pm – 3:00 pm First-line datopotamab deruxtecan (Dato-DXd) vs. chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: exploratory analysis of patients with brain metastases in TROPION-Breast02 R. Dent LBA96 Proffered Paper Presentation Saturday, October 24 8:30 am – 10:00 am First-line trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant NSCLC: patient-reported outcomes from DESTINY-Lung04 S. Novello LBA74 Rapid Oral Presentation Saturday, October 24 8:30 am – 10:00 am DESTINY-Breast09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab for patients with HER2+ advanced/metastatic breast cancer and baseline brain metastases C. Saura LBA49 Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Breast DESTINY-Breast11: MRI-assessed objective responses during neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab vs. dose-dense doxorubicin + cyclophosphamide followed by THP in HER2+ early breast cancer J.F. Boileau 543RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Patient-reported outcomes from DESTINY-Breast05: health-related quality of life with trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with high-risk HER2 positive early breast cancer C. Barrios 539RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Paired-biopsy multi-omic analysis reveals target-independent mechanisms of antibody-drug conjugate resistance in metastatic breast cancer P. Tarantino 4449RO Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Trastuzumab deruxtecan (T-DXd) vs. physician’s choice of chemotherapy in HR+, HER2 low metastatic breast cancer: a DESTINY-Breast06 ctDNA molecular response analysis G. Curigliano 4279P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Trastuzumab deruxtecan (T-DXd) + pembrolizumab in previously treated human epidermal growth factor receptor 2-expressing advanced or metastatic breast cancer: primary analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106 H. Rugo 1771P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm DESTINY-Breast Respond HER2 low Europe non-interventional study of trastuzumab deruxtecan (T-DXd) in HER2 low metastatic breast cancer: update on baseline characteristics and anti-emetic treatment J.Y. Pierga 12P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Improving accuracy in HER2 ultralow identification: multi-site validation of an AI-decision support tool B. Van der Vegt 1784P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Comparative evaluation of 7 artificial intelligence tools for HER2-low and ultralow scoring in breast cancer J.S. Frenel 287P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm A global, interventional, open-label trial of trastuzumab deruxtecan (T-DXd)-based therapy followed by palbociclib, endocrine therapy, and dual HER2 blockade in first-line human epidermal growth factor receptor positive, hormone receptor-positive advanced or metastatic breast cancer and retreatment with T-DXd (DESTINY-Breast Guide) S. Sammons 1795TiP Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Lung NeoCOAST-2: association of ctDNA clearance with clinical outcomes in a global platform phase 2 perioperative trial T. Cascone 4244RO Rapid Oral Presentation Sunday, October 25 8:30 am – 10:00 am Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer in TROPION Lung01 N. Girard 4451P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: IDeate-Lung01 updated results M. Ahn 3842P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Ovarian Raludotatug deruxtecan (R-DXd) + bevacizumab in participants with platinum-resistant recurrent ovarian cancer: results for cohort B-1 of the phase 1b/2 REJOICE-Ovarian02 study A. Oaknin 1247RO Rapid Oral Presentation Saturday, October 24 08:30 am – 10:00 am Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: an updated analysis of efficacy and tolerability from the phase 2 part of REJOICE-Ovarian01 K. Hasegawa 1331P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm A randomized phase 2, open-label, multicenter, study of trastuzumab deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14) J.Y. Lee 1335TiP Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Gastric Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma from DESTINY-Gastric04 M. Gumus 2925P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm Perioperative trastuzumab deruxtecan plus capecitabine and durvalumab in HER2 positive gastric or gastroesophageal junction cancer: a phase II study (EPOC2003) D. Takahari 2888P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm PanTumor Final results of the TUXEDO-3 phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases and leptomeningeal disease M. Preusser 690O Proffered Paper Presentation Sunday, October 25 10:15 am – 11:45 am Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: primary analysis from HERTHENA-PanTumor01 M. McKean 2073RO Rapid Oral Presentation Sunday, October 25 10:15 am – 11:45 am ESPERANZA: Results from an external comparator study of trastuzumab deruxtecan in HER2 IHC3+ solid tumors F. Meric-Bernstam 1014P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan Jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

临床2期临床3期临床结果抗体药物偶联物免疫疗法

2026-10-19

·ioncology

ESMO Asia 2026｜瞭望前瞻，百余项中国消化道肿瘤研究闪狮城，不止参与，更是主角

点击蓝字关注我们编者按欧洲肿瘤内科学会亚洲年会（ESMO Asia）是亚太地区肿瘤领域极具影响力的多学科学术盛会，聚焦亚洲高发肿瘤特征、区域人群的诊疗差异，同步传递全球前沿肿瘤研究进展，也是展示中国本土肿瘤原创研究成果、促进亚欧肿瘤学界交流的核心国际平台。2026 ESMO Asia定于12月4~6日在新加坡举办。本届大会消化道肿瘤板块亮点纷呈，共有100余项由中国学者牵头/主导的研究成功入选，研究谱系完整覆盖肝癌、胆道肿瘤、胰腺癌、胃癌、食管癌、胃食管肿瘤及结直肠癌等消化道瘤种。本文将系统梳理本次ESMO Asia入选的中国消化道肿瘤相关研究，第一时间速递来自国际舞台的中国原创循证证据，解读前沿发现。肝癌 Poster&ePoster 海报&电子海报摘要号：399eTiP 英文标题：Acarbose Combined with Camrelizumab (Cam) Plus Rivoceranib (Rivo) as First-Line Treatment for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombus (PVTT): A Prospective, Single-Arm, Phase II Clinical Study中文标题：阿卡波糖联合卡瑞利珠单抗（Cam）与阿帕替尼（Rivo）一线治疗伴门静脉癌栓（PVTT）的肝细胞癌（HCC）：一项前瞻性、单臂Ⅱ期临床研究讲者：Tao Han (Shenyang, CN) 摘要号：379eP 英文标题：TKI combined with immunotherapy and interventional therapy for advanced hepatocellular carcinoma with PVTT: a retrospective study中文标题：TKI联合免疫疗法和介入疗法治疗伴有门静脉癌栓的晚期肝细胞癌：一项回顾性研究讲者：Feng Xia (Chongqing, CN) 摘要号：378eP 英文标题：TKI vs Bevacizumab Combined with Immune Checkpoint Inhibitors Plus Interventional Therapy for First-Line Treatment of Advanced HCC with PVTT: A Multi-center Retrospective Study中文标题：TKI对比贝伐珠单抗联合免疫检查点抑制剂及介入治疗用于伴门静脉癌栓晚期肝细胞癌的一线治疗：一项多中心回顾性研究讲者：Changde Guo (Chongqing, CN) 摘要号：377eP 英文标题：Phase II trial of para-toluenesulfonamide (PTS), a novel liquid intratumoral ablative agent, plus TACE in unresectable HCC中文标题：新型瘤内液体消融剂对甲苯磺酰胺（PTS）联合TACE治疗不可切除肝细胞癌的Ⅱ期研究讲者：Tao Hai (Chengdu, CN) 摘要号：376eP 英文标题：Perioperative Adebrelimab Combined With Lenvatinib in Resectable Hepatocellular Carcinoma: A Multicenter Phase II Study中文标题：阿得贝利单抗联合仑伐替尼围手术期治疗可切除肝细胞癌：一项多中心Ⅱ期研究讲者：Guang Tan (Dalian, CN) 摘要号：375eP 英文标题：SERPINE2 Drives Immunotherapy Resistance via Remodeling Tumor Metabolism in Hepatocellular Carcinoma中文标题：SERPINE2通过重塑肝细胞癌的肿瘤代谢驱动免疫治疗耐药性讲者：Wentao Zhao (Hangzhou, CN) 摘要号：374eP 英文标题：GPD1 Restrains AARS1-Dependent Histone Lactylation to Reprogram Glutamine Competition in Hepatocellular Carcinoma中文标题：GPD1抑制AARS1依赖的组蛋白乳酰化，从而重编程肝细胞癌中的谷氨酰胺竞争讲者：Chi Zhang (Hangzhou, CN) 摘要号：373eP 英文标题：The PHPT1–PTPN1–EGFR axis and lenvatinib response in hepatocellular carcinoma中文标题：PHPT1-PTPN1-EGFR信号轴与肝细胞癌仑伐替尼药物应答讲者：Zheng Lei (Hangzhou, CN) 摘要号：371P 英文标题：GMFB Drives Mitochondrial Dysfunction and Promotes MASH Progression via Inhibition of Mitophagy中文标题：GMFB通过抑制线粒体自噬驱动线粒体功能障碍并促进MASH进展讲者：Weilin Wang (Hangzhou, CN) 摘要号：370P 英文标题：First-in-human phase I study of HH-009, an anti-FGF19 monoclonal antibody, in patients with advanced solid tumors中文标题：HH-009（一种抗FGF19单克隆抗体）在晚期实体瘤患者中的首次人体Ⅰ期研究讲者：Jinhui Xue (Guangzhou, CN) 摘要号：332P 英文标题：The activity and safety of icaritin in patients with child pugh ≥8 unresectable hepatocellular carcinoma: A real-world exploratory study中文标题：淫羊藿素用于Child-Pugh评分≥8分的不可切除肝细胞癌患者的疗效与安全性：一项真实世界探索性研究讲者：Dinghu Zhang (Hangzhou, CN) 摘要号：329P 英文标题：Prognostic Value of Binary-CR in Hepatocellular Carcinoma: Post Hoc Analysis of the TALENTACE Study中文标题：二元完全缓解（Binary-CR）在肝细胞癌中的预后价值：TALENTACE研究事后分析讲者：Linan Yin (Harbin, CN) 摘要号：328P 英文标题：Donafenib Combined with HAIC, Icaritin, and Tislelizumab as First-Line Therapy for Unresectable Hepatocellular Carcinoma (uHCC): An Open-Label, Single-Arm Exploratory Study中文标题：多纳非尼联合肝动脉灌注化疗、淫羊藿素及替雷利珠单抗一线治疗不可切除肝细胞癌（uHCC）：一项开放标签、单臂探索性研究讲者：Hui Zeng (Hangzhou, CN) 摘要号：327P 英文标题：Comparative Effectiveness and Prognostic Factors of TACE, Targeted‑Immunotherapy, and Their Combination in Hepatocellular Carcinoma Beyond the Up‑to‑7 Criteria: An IPTW‑Adjusted Retrospective Analysis中文标题：经动脉化疗栓塞术（TACE）、靶向免疫疗法及其联合治疗在超出UPTO-7标准的肝细胞癌中的疗效比较及预后因素：一项基于逆概率加权（IPTW）调整的回顾性分析讲者：Xuwei Guo (Shijiazhuang, CN) 摘要号：326P 英文标题：Conversion outcomes following Yttrium-90 radioembolization-based multidisciplinary treatment for hepatocellular carcinoma: a real-world single-center study中文标题：钇-90放射性栓塞治疗肝细胞癌的多学科综合治疗后的转化结果：一项真实世界单中心研究讲者：JUN FU (Fuzhou, CN) 摘要号：323P 英文标题：Transarterial chemoembolisation plus adebrelimab and apatinib for intermediate-to-advanced hepatocellular carcinoma: a multicentre phase II study中文标题：经动脉化疗栓塞联合阿得贝利单抗与阿帕替尼治疗中晚期肝细胞癌：一项多中心Ⅱ期研究讲者：Junming Xu (Zhangzhou, CN) 摘要号：322P 英文标题：Deferred Immunotherapy Following Induction Arterial Chemotherapy for High-risk Unresectable Hepatocellular Carcinoma: A Biomarker-Guided Strategy from a Long-Term Real-World Cohort中文标题：高危不可切除肝细胞癌诱导动脉化疗后延迟免疫治疗：基于长期真实世界队列的生物标志物指导策略讲者：Ming Zhao (Guangzhou, CN) 摘要号：321P 英文标题：Developing a prognostic score for unresectable hepatocellular carcinoma (uHCC) treated with on-demand transarterial chemoembolisation combined with atezolizumab and bevacizumab (TACE+atezo+bev): a post hoc analysis of the TALENTACE trial中文标题：构建按需经动脉化疗栓塞联合阿替利珠单抗+贝伐珠单抗（TACE+atezo+bev）治疗不可切除肝细胞癌（uHCC）的预后评分模型：TALENTACE研究的事后分析讲者：Yonghong Zhang (Beijing, CN) 摘要号：320P 英文标题：FOLFOX-based HAIC plus lenvatinib and cadonilimab for conversion of unresectable hepatocellular carcinoma (HCC): The phase II CCGLC-011 trial中文标题：基于FOLFOX方案的肝动脉灌注化疗联合仑伐替尼与卡度尼利单抗用于不可切除肝细胞癌的转化治疗：Ⅱ期CCGLC-011研究讲者：Han Gao (Wuhan, CN) 摘要号：315P 英文标题：Real-world Adjuvant Treatment Patterns in Chinese Patients with Hepatocellular Carcinoma Following Curative Surgery or Ablation: A Nationwide Physician Survey中文标题：中国肝细胞癌患者根治性手术或消融术后辅助治疗模式的真实世界研究：一项全国性医生调查讲者：Shengyu Huang (Shanghai, CN) 摘要号：314P 英文标题：Neoadjuvant Lenvatinib, Tislelizumab and Hepatic Arterial Infusion Chemotherapy Followed by Adjuvant Tislelizumab for High-Risk Resectable Hepatocellular Carcinoma: A Phase II Trial中文标题：仑伐替尼联合替雷利珠单抗与肝动脉灌注化疗新辅助治疗，序贯替雷利珠单抗辅助治疗高危可切除肝细胞癌：一项Ⅱ期研究讲者：Weihang Lin (Wenzhou, CN) 摘要号：312P 英文标题：Perioperative finotonlimab plus bevacizumab in resectable hepatocellular carcinoma at high risk of recurrence: A prospective, multicenter, single-arm study中文标题：围手术期菲诺利单抗联合贝伐珠单抗治疗复发高风险可切除肝细胞癌：一项前瞻性、多中心、单臂研究讲者：Zhi-Yong Huang (Wuhan, CN) 摘要号：310P 英文标题：M2 macrophage-derived galectin-9 promotes hepatocellular carcinoma progression by enhancing SLC1A5 membrane stability and glutamine metabolismal中文标题：M2巨噬细胞来源的半乳糖凝集素-9通过增强SLC1A5膜稳定性及谷氨酰胺代谢促进肝细胞癌进展讲者：Yujing Guo (Xi'an, CN) 摘要号：309P 英文标题：Dual MET/AXL Inhibition Suppresses Hepatocellular Carcinoma through Tumour Cell–Intrinsic and Microenvironment-Dependent Mechanisms中文标题：MET/AXL双重抑制通过肿瘤细胞内在机制和微环境依赖性机制抑制肝细胞癌讲者：Chenjing Zhu (Nanjing, CN) 摘要号：308P 英文标题：177Lu-KBD881: A Potent and Selective GPC3-Targeting Radiopharmaceutical Drug Conjugate (RDC) for the Treatment of Hepatocellular Carcinoma中文标题：177Lu-KBD881：一种高效且选择性的GPC3靶向放射性药物偶联物（RDC），用于治疗肝细胞癌讲者：Hongzhu Chu (Chengdu, CN) 摘要号：307P 英文标题：The KCNN4-SLC3A2 Axis and Ferroptosis in the Modulation of Lenvatinib Responsiveness in Hepatocellular Carcinoma中文标题：KCNN4-SLC3A2与铁死亡调控肝细胞癌对仑伐替尼的药物应答讲者：Jun Ran Chen (Hangzhou, CN) 摘要号：306P 英文标题：TRAPPC4-Targeting Biomimetic Nanoparticles Restore MHC Class I Antigen Presentation, Reverse Immune Evasion, and Sensitize Hepatocellular Carcinoma to Anti-PD-1 Therapy中文标题：靶向TRAPPC4的仿生纳米颗粒可恢复MHC Ⅰ类抗原呈递，逆转免疫逃逸，并增强肝细胞癌对PD-1抑制剂的敏感性讲者：Sha Yin (Xi'an, CN) 摘要号：305P 英文标题：Association of tertiary lymphoid structure localization and density with prognosis in hepatocellular carcinoma中文标题：三级淋巴结构定位和密度与肝细胞癌预后的关系讲者：Lei-po Lin (Nanning, CN) 摘要号：301P 英文标题：A phospholipid metabolism-based risk signature identifies PCYT1A as a functional regulator of hepatocellular carcinoma progression中文标题：基于磷脂代谢的风险特征表明，PCYT1A是肝细胞癌进展的功能性调节因子讲者：Nan Hu (Beijing, CN) 摘要号：296P 英文标题：Pretreatment emotional distress and immune checkpoint inhibitor efficacy in hepatocellular carcinoma: the SOLACE prospective cohort study中文标题：肝细胞癌患者治疗前情绪困扰与免疫检查点抑制剂疗效的关系：SOLACE前瞻性队列研究讲者：Lin Ye (Guilin, CN) 胆道肿瘤 Poster&ePoster 海报&电子海报摘要号：388eP 英文标题：First-line dual HER2-targeted therapy plus chemotherapy for patients with HER2-expressing advanced biliary tract cancer: Preliminary results from a prospective study中文标题：一线双重HER2靶向治疗联合化疗治疗HER2表达阳性的晚期胆道癌患者：一项前瞻性研究的初步结果讲者：Yang Ge (Beijing, CN) 摘要号：387eP 英文标题：Prospective multicenter study of first-line inetetamab-based combination therapy for HER2-positive advanced biliary tract cancer中文标题：一项前瞻性多中心研究，评估以伊尼妥单抗为基础的一线联合疗法治疗HER2阳性晚期胆道癌的疗效讲者：Feng Xie (Shenghai, CN) 摘要号：383eP 英文标题：A retrospective study on application of biliary stents in adult liver transplantation中文标题：成人肝移植中胆道支架应用的回顾性研究讲者：Zhongquan Sun (Hangzhou, CN) 摘要号：382eP 英文标题：Selection of Postoperative Adjuvant Therapy Regimens and Efficacy Assessment in Intrahepatic Cholangiocarcinoma中文标题：肝内胆管癌术后辅助治疗方案的选择及疗效评估讲者：Yang Huang (Hangzhou, CN) 摘要号：369P 英文标题：Establishing a Pan-Asia Biliary Tract Cancer Virtual MDT Network: Insights on gaps, priorities, and regional roadmap中文标题：建立泛亚洲胆道癌虚拟多学科团队网络：关于差距、优先事项和区域路线图的见解讲者：Shukui Qin (Nanjing, CN) 摘要号：368P 英文标题：Reducing Regional Disparities in Hepatobiliary Cancer Care Through a Virtual MDT: A Real-World Case from Fuyang, China中文标题：通过虚拟多学科团队减少肝胆肿瘤诊疗中的区域差异：来自中国阜阳的真实案例讲者：Lian-Xin Liu (Hefei, CN) 摘要号：366P 英文标题：Post-acute COVID Monitoring and Timing Assessment of Surgery in Chinese Patients with Hepatobiliary Malignancies and SARS-CoV-2 Infection: A Prospective Observational Study中文标题：中国肝胆恶性肿瘤合并SARS-CoV-2感染患者COVID-19急性期后监测及手术时机评估：一项前瞻性观察研究讲者：Changcheng Tao (Beijing, CN) 摘要号：362P 英文标题：Mapping the nerve-tumour frontier in gallbladder cancer by spatial multi-omics中文标题：利用空间多组学方法绘制胆囊癌神经肿瘤边界图谱讲者：Huisi He (Shanghai, CN) 摘要号：361P 英文标题：Efficacy and Conversion Potential of Gemcitabine-Cisplatin Combined with Immunotherapy and Targeted Therapy in Advanced Biliary Tract Cancer: A Real-World Study中文标题：吉西他滨-顺铂联合免疫疗法和靶向疗法治疗晚期胆道癌的疗效和转化潜力：一项真实世界研究讲者：Lang Chen (Chengdu, CN) 摘要号：360P 英文标题：OLFM4, FGFR1 signalling and neutrophil remodelling in biliary tract cancer中文标题：OLFM4、FGFR1信号通路和中性粒细胞重塑在胆道癌中的作用讲者：Huisi He (Shanghai, CN) 摘要号：357P 英文标题：Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and pucotenlimab for conversion of initially unresectable intrahepatic cholangiocarcinoma (iCCA): The phase II CCGLC-013 trial中文标题：肝动脉灌注化疗（HAIC）联合仑伐替尼与普特利单抗用于初始不可切除肝内胆管癌（iCCA）的转化治疗：Ⅱ期CCGLC-013研究讲者：Han Gao (Wuhan, CN) 摘要号：353P 英文标题：Composite Biomarker Profiling Identifies Large Duct Type Intrahepatic Cholangiocarcinoma as a Chemotherapy-Responsive Subtype中文标题：复合生物标志物分析鉴定出大导管型肝内胆管癌为化疗敏感亚型讲者：Zhuo Li (Beijing, CN) 摘要号：352P 英文标题：A CXCL10+ Macrophage-Centred Spatial Immune Niche Is Associated With Response to Camrelizumab Plus GEMOX in Unresectable Gallbladder Cancer中文标题：以CXCL10⁺巨噬细胞为核心的空间免疫微环境生态位与不可切除胆囊癌患者卡瑞利珠单抗联合GEMOX方案的治疗应答相关讲者：Wanying Deng (Guangzhou, CN) 摘要号：348P 英文标题：Peripheral nerve infiltration affects the efficacy of neoadjuvant immunotherapy for intrahepatic cholangiocarcinoma中文标题：周围神经浸润影响肝内胆管癌新辅助免疫疗法的疗效讲者：Shu Lizhuang (Shanghai, CN) 摘要号：347P 英文标题：Durvalumab/Pembrolizumab plus Gemcitabine, Cisplatin, and Surufatinib for Advanced Biliary Tract Cancer: A Phase 2 Study中文标题：度伐利尤单抗/帕博利珠单抗联合吉西他滨、顺铂与索凡替尼治疗晚期胆道恶性肿瘤：一项Ⅱ期研究讲者：Miaomiao Gou (Beijing, CN) 摘要号：345P 英文标题：Gemcitabine-based chemotherapy plus PD-1/PD-L1 inhibitors and tyrosine kinase inhibitors for initially unresectable intrahepatic cholangiocarcinoma: A multicenter, retrospective cohort study中文标题：吉西他滨为基础的化疗联合PD-1/PD-L1抑制剂及酪氨酸激酶抑制剂治疗初始不可切除肝内胆管癌：一项多中心回顾性队列研究讲者：Yuan Ding (Hangzhou, CN) 胰腺癌 Poster&ePoster 海报&电子海报摘要号：396eP 英文标题：Efficacy and safety of splenic artery infusion chemotherapy versus systemic chemotherapy in advanced pancreatic body/tail cancer: a real-world study中文标题：脾动脉灌注化疗与全身化疗治疗晚期胰体尾癌的疗效和安全性：一项真实世界研究讲者：Jianfeng Huang (Guangzhou, CN) 摘要号：343P 英文标题：Efficacy and safety of chemoimmunotherapy in advanced pancreatic cancer中文标题：化疗免疫疗法治疗晚期胰腺癌的疗效和安全性讲者：Hanqi Yu (Hangzhou, CN) 摘要号：342P 英文标题：Personalized mRNA Cancer Vaccine in Pancreatic Cancer: Feasibility, Safety, and Preliminary Biomarker Signals from Real-World Data中文标题：胰腺癌个性化mRNA癌症疫苗：可行性、安全性及来自真实世界数据的初步生物标志物信号讲者：Mantang Qiu (Beijing, CN) 摘要号：341P 英文标题：Neoadjuvant PD-1 Blockade (Toripalimab) Combined with Gemcitabine and Nab-Paclitaxel for Borderline Resectable and Locally Advanced Pancreatic Cancer: A Prospective Interventional Study中文标题：新辅助PD-1阻断（特瑞普利单抗）联合吉西他滨和白蛋白紫杉醇治疗临界可切除和局部晚期胰腺癌：一项前瞻性干预研究讲者：Ziheng Guo (Chengdu, CN) 摘要号：340P 英文标题：Fruquintinib monotherapy as third-line or later treatment for advanced pancreatic ductal adenocarcinoma: Updated results from a multicenter phase II study中文标题：呋喹替尼单药用于晚期胰腺导管腺癌三线及以上治疗：一项多中心Ⅱ期研究更新结果讲者：Jieyun Zhang (Shanghai, CN) 摘要号：338P 英文标题：Synthetic Lethality Targeting IL-1β in KRAS-Mutant Cancer中文标题：针对KRAS突变癌症中IL-1β的合成致死性讲者：Yukai Shan (Hangzhou, CN) 胃癌 Rapid Oral session 快速口头报告摘要号：1044RO 英文标题：Personalized MRD Monitoring Predicts Recurrence and Guides Tailored Adjuvant Therapy in Post-Neoadjuvant Locally Advanced Gastric Cancer: A Prospective, Multicenter Cohort Study中文标题：个体化MRD监测预测新辅助治疗后局部晚期胃癌复发并指导个体化辅助治疗：一项前瞻性、多中心队列研究讲者：李子禹（北京大学肿瘤医院） Poster&ePoster 海报&电子海报摘要号：YO30 英文标题：Gastric hepatoid adenocarcinoma achieving pathological complete response after conversion therapy with chemotherapy, trastuzumab, and cadonilimab: a case report中文标题：一例胃肝样腺癌经化疗、曲妥珠单抗和卡度尼利单抗转化治疗后达到病理完全缓解的病例报告讲者：Yarong Li (Taiyuan, CN) 摘要号：1092eP 英文标题：Irinotecan liposome combined with albumin-bound paclitaxel in second-line therapy of advanced gastric cancer: A Single-Arm, Single-Center Clinical Study中文标题：伊立替康脂质体联合白蛋白结合型紫杉醇二线治疗晚期胃癌：一项单臂、单中心临床研究讲者：Rongrong Li (Changsha, CN) 摘要号：1089eP 英文标题：Association between the age-adjusted Charlson Comorbidity Index and postoperative survival in patients with gastric cancer中文标题：年龄校正查尔森合并症指数与胃癌患者术后生存的相关性研究讲者：Yulan Lin (Fuzhou, CN) 摘要号：1086eP 英文标题：Immune-Stromal Characterization of HER2/PD-L1-Defined Subtypes in Gastric Cancer中文标题：胃癌中HER2/PD-L1定义亚型的免疫基质特征分析讲者：Ming-Huang Chen (Taipei City, TW) 摘要号：1076P 英文标题：Multi-Task Deep Learning for Endoscopic Differentiation of Type 1 Grade 1/2 Gastric Neuroendocrine Tumors, Gastric Polyps, and Gastrointestinal Stromal Tumors中文标题：基于多任务深度学习的内镜鉴别诊断：Ⅰ型1/2级胃神经内分泌肿瘤、胃息肉和胃肠道间质瘤讲者：Jiaojiao Hou (Shijiazhuang, CN) 摘要号：1072P 英文标题：Envafolimab Combined with XELOX or SOX as Adjuvant Therapy for Locally Advanced Gastric Cancer: A Prospective, Single-Arm, Exploratory Study中文标题：Envafolimab联合XELOX或SOX方案辅助治疗局部晚期胃癌：一项前瞻性、单臂、探索性研究讲者：Danyu Ma (Wuxi, CN) 摘要号：1055P 英文标题：Peripheral CD8+ T Cell Senescence and Lymphocyte Reduction Emerge at Premalignant Gastric Stages中文标题：外周CD8+ T细胞衰老和淋巴细胞减少出现在胃癌前期阶段讲者：Da-cen Lin (Fuzhou, CN) 摘要号：1054P 英文标题：Single-cell profiling of gastric mucosal remodeling in zolbetuximab-induced gastritis 中文标题：佐妥昔单抗诱导胃炎中胃黏膜重塑的单细胞图谱分析讲者：Miaomiao Gou (Beijing, CN) 摘要号：1053P 英文标题：Baseline clinicogenomic modeling of response groups in gastric cancer treated with immunochemotherapy中文标题：免疫化疗治疗胃癌患者反应组的基线临床基因组学模型讲者：Xin Han (Shijiazhuang, CN) 摘要号：1052P 英文标题：Correlation between Dynamic Changes in Natural Killer Cell Activity, Nutritional Status and Therapeutic Efficacy in Patients with Advanced Gastric Cancer中文标题：晚期胃癌患者自然杀伤细胞活性动态变化、营养状况与治疗效果的相关性研究讲者：Dan Wu (Hefei, CN) 摘要号：1051P 英文标题：The Impact of Delayed Diagnosis and Treatment on Self-Reported Quality of Life in Gastric Cancer Patients: A Prospective Cohort Study中文标题：延迟诊断和治疗对胃癌患者自述生活质量的影响：一项前瞻性队列研究讲者：Xinyu Chen (Fuzhou, CN) 食管癌 Proffered Paper session 优选论文专场摘要号：1043O 英文标题：Primary Results of Risvutatug Rezetecan (Ris-Rez) in Patients with Advanced Esophageal Squamous-Cell Carcinoma (ESCC): A Phase 2 Clinical Trial中文标题：Risvutatug Rezetecan（Ris-Rez）治疗晚期食管鳞状细胞癌（ESCC）患者的初步结果：一项Ⅱ期临床试验讲者：李宁（河南省肿瘤医院） Poster&ePoster 海报&电子海报摘要号：1065P 英文标题：Camrelizumab plus paclitaxel and nedaplatin conversion therapy in ESCC: A single-arm phase II trial with retrospective biomarker analysis of combined CUL4A and HSP90β for survival prediction中文标题：卡瑞利珠单抗联合紫杉醇和奈达铂治疗ESCC：一项单臂Ⅱ期临床试验，回顾性分析CUL4A和HSP90β联合生物标志物对生存预测的价值讲者：Jinhong Zhu (Harbin, CN) 摘要号：1064P 英文标题：The Efficacy and Safety of Cetuximab β plus Tislelizumab and Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (CTC-LAESCC): single-arm, phase II study中文标题：西妥昔单抗β联合替雷利珠单抗及放化疗治疗局部晚期食管鳞癌：CTC-LAESCC单臂Ⅱ期研究讲者：Xiuyong Liao (Chongqing, CN) 摘要号：1063P 英文标题：Adebrelimab plus albumin-paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma: a multicenter, single-arm, phase II study中文标题：阿得贝利单抗联合白蛋白紫杉醇与奈达铂用于可切除局部晚期食管鳞癌的新辅助治疗：一项多中心、单臂Ⅱ期研究讲者：Jianqun Ma (Harbin, CN) 摘要号：1060P 英文标题：Survival Outcomes and Ultrasound Radiomics Prognostication in Cervical Lymph Node Oligometastasis Post-Esophagectomy: A Multicenter Retrospective Study Comparing Surgical and Non-Surgical Approaches中文标题：食管切除术后颈部淋巴结寡转移的生存结局与超声组学预后预测：一项对比手术与非手术治疗方案的多中心回顾性研究讲者：Junying Chen (Guangzhou, CN) 摘要号：1059P 英文标题：Preliminary results for a phase II study of sintilimab combined with chemotherapy followed by concurrent chemoradiotherapy as conversion therapy for unresectable locally advanced esophageal squamous cell carcinoma (NICE-CS trial)中文标题：信迪利单抗联合化疗序贯同步放化疗作为不可切除局部晚期食管鳞癌转化治疗的Ⅱ期研究初步结果（NICE-CS研究）讲者：Yuxi Yi (Shanghai, CN) 摘要号：1058P 英文标题：Anlotinib plus Toripalimab with Neoadjuvant Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Trial中文标题：安罗替尼联合特瑞普利单抗序贯新辅助放化疗治疗局部晚期食管鳞癌：一项Ⅱ期临床试验讲者：Qiwei Yao (Fuzhou, CN) 摘要号：1056P 英文标题：Development and validation of a clinical decision score to guide adjuvant therapy in esophageal squamous cell carcinoma after neoadjuvant immunochemotherapy中文标题：开发和验证临床决策评分，以指导新辅助免疫化疗后食管鳞状细胞癌的辅助治疗讲者：Haiping Jiang (Hangzhou, CN) 摘要号：1049P 英文标题：A Multicenter, Real-world Study on Impact of Smoking on Clinical Outcomes and the Tumor Immune Microenvironment in Metastatic ESCC Patients Receiving First-Line PD-1 Inhibitors: A Role for CD8+ TIL Infiltration中文标题：一项多中心、真实世界研究评估吸烟对接受一线PD-1抑制剂治疗的转移性食管鳞状细胞癌（ESCC）患者的临床结局和肿瘤免疫微环境的影响：CD8+肿瘤浸润淋巴细胞浸润的作用讲者：Fan Dong (Guangzhou, CN) 胃食管肿瘤 Poster&ePoster 海报&电子海报摘要号：1096P 英文标题：Fruquintinib combined with cadonilimab and nab-paclitaxel as second‑line treatment for advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC)中文标题：呋喹替尼联合卡度尼利单抗和白蛋白紫杉醇作为晚期胃或胃食管交界处腺癌（GC/GEJC）的二线治疗讲者：Jieyun Zhang (Shanghai, CN) 摘要号：1068P 英文标题：Long-term survival follow-up of camrelizumab plus Nab-POF conversion therapy in initially unresectable locally advanced or limited metastatic gastric or gastroesophageal junction adenocarcinoma: FDZL-GC001中文标题：卡瑞利珠单抗联合Nab-POF转化疗法治疗初始不可切除的局部晚期或局限性转移性胃癌或胃食管交界处腺癌的长期生存随访：FDZL-GC001讲者：Wanjing Feng (Shanghai, CN) 摘要号：1067P 英文标题：Biomarker-Driven Assessment of Immunochemotherapy with or without Fruquintinib as First-Line Treatment for Advanced Gastric/GEJ Adenocarcinoma: Initial Clinical Results and Subgroup Analysis from the MGC-FLORA Study中文标题：基于生物标志物的免疫化疗联合或不联合呋喹替尼作为晚期胃/GEJ腺癌一线治疗的评估：MGC-FLORA研究的初步临床结果和亚组分析讲者：Chenchen Wang (Shanghai, CN) 摘要号：1066P 英文标题：HCB101 with ramucirumab and paclitaxel as a CD47–SIRPα innate immune combination strategy in previously treated advanced gastric/GEJ cancer中文标题：HCB101联合雷莫芦单抗和紫杉醇作为CD47-SIRPα先天免疫联合策略，用于治疗既往接受过治疗的晚期胃/GEJ癌讲者：Fangling Ning (Yantai, CN) 结直肠癌 Proffered Paper session 优选论文专场摘要号：152O 英文标题：Regorafenib Combined with Trifluridine/Tipiracil versus Regorafenib Monotherapy in Refractory Metastatic Colorectal Cancer (FDZL-REGOT): A Randomized Phase II Trial中文标题：瑞戈非尼联合曲氟尿苷/替匹嘧啶对比瑞戈非尼单药治疗难治性转移性结直肠癌（FDZL-REGOT）：一项随机Ⅱ期试验讲者：李文桦（复旦大学附属肿瘤医院） Rapid Oral session 快速口头报告摘要号：154RO 英文标题：Amivantamab monotherapy or in combination with chemotherapy in RAS/BRAF wildtype metastatic colorectal cancer: Asian subset analysis from the phase 1b/2 OrigAMI-1 study中文标题：埃万妥单抗单药或联合化疗治疗RAS/BRAF野生型转移性结直肠癌：Ⅰb/Ⅱ期OrigAMI-1研究的亚洲亚组分析讲者：袁瑛（浙江大学医学院附属第二医院）摘要号：155RO 英文标题：Single-cell transcriptomic atlas reveals myeloid reprogramming and persistent clonal T-cell expansion underlying pathological complete response to split-course hypofractionated chemoradioimmunotherapy in pMMR/MSS locally advanced rectal cancer中文标题：单细胞转录组图谱揭示pMMR/MSS局部晚期直肠癌分段大分割放化疗联合免疫治疗病理完全缓解的髓系重编程与持续性克隆性T细胞扩增机制讲者：郑榕（福建医科大学附属协和医院）摘要号：1046RO 英文标题：SYS6010 combined with SYH2051 in advanced solid tumors: results from a phase Ib中文标题：SYS6010联合SYH2051治疗晚期实体瘤：一项Ⅰb期研究结果讲者：林榕波（福建省肿瘤医院）摘要号：1047RO 英文标题：Safety and feasibility of CLDN18.2-specific CAR-NK cells in advanced gastrointestinal cancers: A phase 1 trial中文标题：CLDN18.2特异性CAR-NK细胞治疗晚期消化道肿瘤的安全性与可行性：一项Ⅰ期试验讲者：杨柳（浙江省人民医院） Poster&ePoster 海报&电子海报摘要号：235eP 英文标题：Oxaliplatin-associated affective toxicity in colorectal cancer is mediated by the IDO1-kynurenine-gut microbiota-ACC neuroimmune axis中文标题：IDO1-犬尿氨酸-肠道菌群-前扣带回皮层神经免疫轴介导结直肠癌中奥沙利铂相关情感毒性讲者：Zhijun Mao (Xian, CN) 摘要号：234eP 英文标题：Trajectories and risk stratification of patient-reported affective toxicity during colorectal cancer chemotherapy: a real-world longitudinal study中文标题：结直肠癌化疗期间患者报告的情感毒性轨迹和风险分层：一项真实世界纵向研究讲者：Yuming Zhang (Xi'an, CN) 摘要号：226eP 英文标题：KBD166: A Novel Neurotensin Receptor 1 (NTSR1) Ligand for Solid Tumor Therapy中文标题：KBD166：用于实体瘤治疗的新型神经降压素受体1（NTSR1）配体讲者：Jing Zhang (Chengdu, CN) 摘要号：224eP 英文标题：Vitamin E plus fruquintinib and tislelizumab in refractory microsatellite-stable metastatic colorectal cancer: interim results of the phase II VENTIF study中文标题：维生素E联合呋喹替尼与替雷利珠单抗治疗难治性微卫星稳定转移性结直肠癌：Ⅱ期VENTIF研究中期结果讲者：Dawei Li (Shanghai, CN) 摘要号：218eP 英文标题： Safety and Feasibility of Preserving the Left Colic Artery and Clearing No.253 Lymph Nodes via Caudal Triangular Region Dissection in LRRRC for Rectal Cancer中文标题：低位局部进展期直肠癌经尾侧三角区清扫保留左结肠动脉并清扫253组淋巴结的安全性与可行性讲者：Pengxing Li (Nanping, CN) 摘要号：201P 英文标题：Fruquintinib Monotherapy Versus Fruquintinib Combined with Chemotherapy in Patients with Refractory Metastatic Colorectal Cancer: A Real-World Retrospective Cohort Study中文标题：呋喹替尼单药对比呋喹替尼联合化疗用于难治性转移性结直肠癌患者：一项真实世界回顾性队列研究讲者：Jen Pei Huang (Taipei City, TW) 摘要号：198P 英文标题：Propensity Score Matching Multicenter Study of Maintenance Strategies versus Drug-free Treatment Break After First-line Systemic Therapy for Metastatic Colorectal Cancer - The Retrospective TRACC Registry中文标题：转移性结直肠癌一线系统治疗后维持治疗策略对比停药治疗间歇的疗效：一项基于TRACC回顾性登记库的多中心倾向性评分匹配研究讲者：Kin Tsun Lee (Hong Kong, HK) 摘要号：197P 英文标题：Antibiotic Exposure Prior to Radiotherapy and Survival Outcomes in Colorectal Cancer: A Propensity Score-Matched Real-World Analysis Using the TriNetX Global Network中文标题：结直肠癌患者放疗前抗生素暴露与生存结局：基于TriNetX全球数据库的倾向性评分匹配真实世界分析讲者：Tisha Lazuana (Taipei City, TW) 摘要号：195P 英文标题：BETTER Trial: The Efficacy and Safety of Bevacizumab Combined with Trifluridine/Tipiracil, Stereotactic Body Radiotherapy, and Tislelizumab in Patients with Microsatellite-Stable Metastatic Colorectal Cancer Receiving Third-Line Therapy中文标题：BETTER研究：贝伐珠单抗联合曲氟尿苷替匹嘧啶、立体定向体部放疗及替雷利珠单抗三线治疗微卫星稳定转移性结直肠癌的疗效与安全性讲者：Qun Zhang (Nanjing, CN) 摘要号：194P 英文标题：UGT1A1 genotype-guided Irinotecan liposome combined with 5-FU/LV+ bevacizumab as first-line therapy in metastatic colorectal cancer：multicenter, phase II clinical study中文标题：基于UGT1A1基因型指导的脂质体伊立替康联合5-FU/LV及贝伐珠单抗一线治疗转移性结直肠癌：一项多中心Ⅱ期临床研究讲者：Yuwen Zhou (Chengdu, CN) 摘要号：193P 英文标题：Precemtabart tocentecan (Precem-TcT) in Chinese patients with metastatic colorectal cancer (mCRC): results from the PROCEADE®-CRC-02 study中文标题：Precemtabart tocentecan (Precem-TcT) 治疗中国转移性结直肠癌 (mCRC) 患者：PROCEADE®-CRC-02研究结果讲者：Yanhong Deng (Guangzhou, CN) 摘要号：192P 英文标题：Sintilimab plus bevacizumab and CapeOx as first-line treatment in RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer patients: Updated survival results and biomarker analyses of the BBCAPX-II study中文标题：信迪利单抗联合贝伐珠单抗与CapeOx方案一线治疗RAS突变、微卫星稳定、不可切除转移性结直肠癌：BBCAPX-Ⅱ研究更新生存结果及生物标志物分析讲者：Ning Zhu (Hangzhou, CN) 摘要号：190P 英文标题：Final analysis of CAPability-01: A phase Il trial of combined anti-PD-1, HDAC inhibitor and anti-VEGF for MSS/pMMR colorectal cancer中文标题：CAPability-01研究最终分析：抗PD-1联合HDAC抑制剂与抗血管内皮生长因子药物治疗 MSS/pMMR结直肠癌的Ⅱ期研究讲者：Yu-Kun Chen (Guangzhou, CN) 摘要号：188P 英文标题：Metastasectomy, hepatic resection margin status, and survival with first-line panitumumab or cetuximab in RAS wild-type metastatic colorectal cancer: a Taiwanese multicenter cohort中文标题：RAS野生型转移性结直肠癌一线使用帕尼单抗或西妥昔单抗治疗时，转移灶切除术、肝切除切缘状态与生存的相关性：一项中国台湾多中心队列研究讲者：Hung-Chih Hsu (Taoyuan City, TW) 摘要号：186P 英文标题：Postoperative intraperitoneal raltitrexed after cytoreductive surgery for colorectal peritoneal metastases: a single-centre, open-label, phase 1b dose-escalation study中文标题：结直肠癌腹膜转移肿瘤减灭术后行术后腹腔内雷替曲塞给药：一项单中心、开放标签、Ⅰb期剂量递增研究讲者：Guoxiang Cai (Shanghai, CN) 摘要号：184P 英文标题：Peritumoral multimodal radiomics predicts CRLM recurrence中文标题：肿瘤周围多模态放射组学预测CRLM复发讲者：Yanzong Lin (Xiamen, CN) 摘要号：183P 英文标题：Time-Varying Relapse Risk and Surveillance Intensity After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastases中文标题：初始无法切除的结直肠癌肝转移患者行转化性肝切除术后，复发风险随时间变化及监测强度讲者：Yijiao Chen (Shanghai, CN) 摘要号：180P 英文标题：CT–MRI Multimodal Imaging-based Characterization of Indeterminate Pulmonary Nodules in Rectal Cancer中文标题：基于CT-MRI多模态成像的直肠癌肺部不确定结节的特征分析讲者：Liao Yijun (Guangzhou, CN) 摘要号：178P 英文标题：Neoadjuvant fruquintinib plus tislelizumab and mCapeOX for pMMR/MSS locally advanced rectal cancer: Safety lead-in results of a prospective, randomized, multicenter trial中文标题：新辅助呋喹替尼联合替雷利珠单抗和mCapeOX方案治疗pMMR/MSS局部晚期直肠癌：一项前瞻性、随机、多中心试验的安全性导入结果讲者：Xiaokang Lei (Beijing, CN) 摘要号：171P 英文标题：Tissue-specific mapping of genetic susceptibility in colorectal cancer identifies epithelial and endothelial driver genes and validates the association between WDR74 and oxaliplatin chemoresistance中文标题：结直肠癌遗传易感性的组织特异性定位鉴定出上皮和内皮驱动基因，并验证了WDR74与奥沙利铂化疗耐药性之间的关联讲者：Tingyao Liu (Zhuhai, CN) 摘要号：168P 英文标题：NAMPT-driven NAD⁺ metabolism orchestrates a tumor stiffness–immune axis that mediates immunotherapy resistance in MSS colorectal cancer中文标题：NAMPT驱动的NAD⁺代谢调控肿瘤硬度-免疫轴，从而介导MSS型结直肠癌的免疫治疗耐药性讲者：Chenyang Ye (Hangzhou, CN) 摘要号：165P 英文标题：Preclinical and first-in-human evaluation of [68Ga]NODAGA-SNA009 for PET imaging of GPA33 expression in colorectal cancer中文标题：[68Ga]NODAGA-SNA009 用于PET成像检测结直肠癌中GPA33表达的临床前和首次人体评估讲者：Dong Dai (Tianjin, CN) 摘要号：164P 英文标题：Attention-enhanced digital pathology for MSI prediction in colorectal cancer中文标题：注意力增强型数字病理学在结直肠癌MSI预测中的应用讲者：Yunxia Huang (Xiamen, CN) 摘要号：156P 英文标题：Smoking promotes colorectal cancer risk mediated by type 2 diabetes: a Mendelian randomization study中文标题：吸烟通过2型糖尿病介导增加结直肠癌风险：一项孟德尔随机化研究讲者：Yu Zhou (Fuzhou, CN) （来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期免疫疗法临床结果

2026-10-19

·汉康生技

汉康生技经科学顾问委员会审议并与FDA达成一致意见推动HCB101迈向全球注册性开发

Persevere far, break through to lead 聚焦时代新赛道激活发展新引擎科技丨发展丨未来丨共赢汉康生技经科学顾问委员会审议并与FDA达成一致意见推动HCB101迈向全球注册性开发六个月临床进展确立二线胃癌为首要临床开发方向，并在二线MSS结直肠癌、HER2阳性胃癌和HNSCC中持续积累概念验证数据，同时通过合作及下一代研究不断拓展价值台北、上海和旧金山 — 2026年10月19日 — 汉康生技股份有限公司（TWSE：7827）是一家致力于开发用于肿瘤及免疫介导疾病的新一代免疫疗法的全球临床阶段生物技术公司。公司今日公布其最新一次科学顾问委员会（SAB）会议成果。会议重点包括：核心管线HCB101取得重要临床进展；公司与美国FDA就二线胃癌/胃食管结合部癌（GC/GEJ）的注册性开发路径达成一致意见；以及公司在肿瘤和免疫介导疾病领域持续拓展研发管线。此次会议标志着HCB101实现了明确的战略转变，即从早期临床概念验证迈向全球开发优化及广泛的联合治疗策略。会议讨论重点包括：将二线GC/GEJ癌确立为临床及注册性开发的核心方向；优化HCB101的剂量和给药方案，以推进全球开发；明确HCB101在MSS结直肠癌和头颈部鳞状细胞癌（HNSCC）中的拓展机会；通过外部联合治疗与合作进一步拓展HCB101的价值。 HCB101临床项目由汉康生技总裁兼首席医学官Alvin Luk博士介绍。 “与六个月前相比，这次SAB会议呈现出截然不同的面貌，也反映出汉康生技取得了显著进展——不仅体现在临床方面，也涵盖研究、转化科学和药物发现等领域。”SAB主席Mingyi Chen教授表示，“HCB101已从生物学概念验证迈向清晰明确的开发战略。与此同时，团队在肿瘤、自身免疫性疾病、胶质母细胞瘤及下一代免疫工程等领域开展了大量新研究。最令我印象深刻的是，公司正以很快的速度将科学构想转化为可用于决策的数据和开发机会。短短六个月内取得的进展确实令人振奋。” 二线胃癌成为核心临床开发方向并与FDA达成一致 SAB审议了HCB101联合雷莫芦单抗和紫杉醇用于二线GC/GEJ癌的积极临床数据。该项GC/GEJ试验的主要结果包括：高缓解率：在5.12 mg/kg和8 mg/kg两个中剂量队列中，HCB101的客观缓解率（ORR）达到63%（10/16例可评估患者），疾病控制率（DCR）达到100%。持久获益：相当比例的患者持续接受治疗超过18周。作为临床背景参考，在以亚洲人群（主要为中国患者）为主开展的III期桥接研究RAINBOW-Asia（NCT01939899）中，雷莫芦单抗联合紫杉醇的ORR为26.5%，中位无进展生存期（PFS）为4.14个月（约18周）。不同试验之间的直接比较应谨慎解读。值得注意的是，在2026年6月与美国FDA举行会议后，汉康生技就分阶段注册性开发策略与FDA达成一致意见。后续路径包括：先开展用于治疗方案筛选的随机II期导入研究，随后开展以总生存期（OS）为主要终点的确证性III期试验。 MSS结直肠癌及头颈部肿瘤中的拓展信号汉康生技展示了HCB101在其他实体瘤领域不断积累的数据：微卫星稳定型（MSS）结直肠癌（CRC）：在一项评估HCB101联合贝伐珠单抗和化疗的二线MSS CRC队列中，HCB101的ORR达到50%（2/4例患者），DCR达到100%。在由申办方发起的更广泛CRC联合治疗队列中，多种标准治疗方案也观察到缓解，支持HCB101在CRC领域与不同治疗方案联合应用的潜力。台湾由研究者发起的补充性临床试验显示，在部分患者中，低剂量HCB101联合贝伐珠单抗和化疗实现了超过48周和64周的持续疾病控制。作为临床背景参考，既往二线贝伐珠单抗联合治疗方案的ORR约为5%–23%，中位PFS为5.7–7.3个月（24–31周）。跨试验比较应谨慎解读。头颈部鳞状细胞癌（HNSCC）：HCB101单药治疗产生了持续超过80周的持久部分缓解。FDA已批准单例患者扩大使用（同情用药），以便患者继续接受治疗。早期联合治疗数据进一步支持HCB101与靶向EGFR和PD-1的疗法联合开发。通过联合治疗合作释放倍增价值 SAB认为，HCB101是一款可灵活联合、以巨噬细胞为作用基础的治疗骨架，而非局限于单一治疗方案的药物。汉康生技正积极评估多种具有科学依据的联合治疗方案，将HCB101与下一代双特异性及多特异性药物、HER2靶向疗法、肿瘤疫苗、抗体偶联药物（ADC）、化疗，以及靶向基质/肿瘤微环境（TME）的药物进行联合。 “六个月前，我们仍在验证HCB101能够实现怎样的潜力。如今，我们已经拥有核心临床开发方向、与FDA达成一致的注册性开发路径、在CRC和HNSCC中不断扩展的临床信号，以及通过合作进一步放大HCB101价值的更多机会。”汉康生技创始人兼董事长刘世高博士表示，“我们的目标不止于一款药物。我们正在依托FBDB™平台打造全球创新引擎，持续将差异化科学转化为高价值药物。” 发现引擎推动多学科研发管线取得进展在首席科学官Wenwu Zhai博士的带领下，汉康生技研发团队展示了公司在肿瘤、自身免疫性疾病、中枢神经系统疾病及心血管生物学领域取得的进展。胶质母细胞瘤（GBM）：汉康生技展示了积极的临床前数据，探索巨噬细胞靶向疗法与标准治疗联合应用，并开发旨在改善药物穿越血脑屏障递送的下一代技术。SAB建议在原位模型中开展进一步验证，并直接证明药物在中枢神经系统中的暴露。自身免疫与心血管生物学：SAB审议了多项下一代治疗策略，旨在更深入、更持久地清除致病性B细胞和抗体产生细胞群体；同时审议了针对难治性自身免疫性疾病相关炎症通路的研发项目。SAB还审议了将巨噬细胞生物学拓展至动脉粥样硬化和斑块稳定领域的探索性研究，重点关注传统降脂之外的潜在价值。关于汉康生技汉康生技（TWSE：7827）是一家全球临床阶段生物技术公司，专注于开发用于治疗癌症和严重免疫相关疾病的变革性免疫疗法。依托专有FBDB™平台，汉康生技设计可重新激活先天免疫和适应性免疫的多功能生物药。公司业务布局覆盖台北、上海和旧金山，致力于将差异化科学转化为具有重要影响力的全球治疗方案。更多信息请访问： www.HanchorBio.com。前瞻性声明本新闻稿包含有关HCB101、HCB301及汉康生技研发管线的开发；初步临床结果的解读及潜在意义；未来临床研究、开发策略、适应症、联合治疗与合作；以及FBDB™平台能力和潜力的前瞻性声明。这些声明基于当前预期和假设，并涉及可能导致实际结果与所述内容存在重大差异的风险和不确定性。随着随访继续进行及数据逐步成熟，初步临床结果可能发生变化。监管沟通不构成批准，也不保证未来开发或产品获批。除适用法律另有要求外，汉康生技不承担更新前瞻性声明的义务。投资者及媒体联系人：电子邮箱：IRPR@hanchorbio.com 汉康生技商务拓展联系人：电子邮箱：BD@HanchorBio.com Persevere far, break through to lead 聚焦时代新赛道激活发展新引擎科技丨发展丨未来丨共赢 HanchorBio Advances HCB101 Toward Global Registrational Development Following SAB Review and FDA Alignment Six months of clinical progress establish 2L gastric cancer as the primary clinical anchor, with expanding proof-of-concept activity across 2L MSS colorectal cancer, HER2+ gastric cancer, and HNSCC, alongside growing value through partnerships and next-generation research TAIPEI, SHANGHAI, and SAN FRANCISCO — October 19, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced outcomes from its latest Scientific Advisory Board (SAB) meeting. Highlights included significant clinical progress for its lead asset, HCB101; alignment with the U.S. FDA on a registrational pathway in second-line gastric/gastroesophageal junction (GC/GEJ) cancer; and continued expansion of the company’s research pipeline across oncology and immune-mediated diseases. The meeting marked a clear strategic transition for HCB101 from early clinical proof of concept toward global development optimization and broad combination strategies. Discussion focused on: Establishing second-line GC/GEJ cancer as the clinical and registrational anchor; Optimizing HCB101 dose and schedule for global development; Defining expansion opportunities in MSS colorectal cancer and HNSCC; and Extending HCB101’s value through external combinations and partnerships. The HCB101 clinical program was presented by Dr. Alvin Luk, President and Chief Medical Officer of HanchorBio. “This was a very different SAB meeting from six months ago and reflected remarkable progress at HanchorBio—not only clinically, but across research, translational science and discovery,” said Professor Mingyi Chen, SAB Chairman. “HCB101 has moved from proof of biology toward a clearly defined development strategy. At the same time, the team has generated an extraordinary amount of new research across oncology, autoimmune disease, glioblastoma, and next-generation immune engineering. What impressed me most was how quickly the organization is turning scientific concepts into actionable data and development opportunities. The progress in just six months is genuinely exciting.” 2L Gastric Cancer Emerges as Clinical Anchor with FDA Alignment The SAB reviewed encouraging clinical data evaluating HCB101 in combination with ramucirumab and paclitaxel in second-line GC/GEJ cancer. Highlights of the GC/GEJ trial include: High Response Rate: HCB101 achieved a 63% objective response rate (ORR) (10/16 evaluable patients) and a 100% disease control rate (DCR) across the 5.12 and 8 mg/kg mid-dose cohorts. Durable Benefit: A substantial proportion of patients remained on treatment beyond 18 weeks. For context, in RAINBOW-Asia (NCT01939899), a Phase 3 bridging study conducted in an Asian, predominantly Chinese population, ramucirumab plus paclitaxel achieved an ORR of 26.5% and a median PFS of 4.14 months (~18 weeks). Direct cross-trial comparisons should be interpreted with caution. Importantly, following a June 2026 meeting with the U.S. FDA, HanchorBio reached alignment on a stepwise registrational strategy. The path forward includes a randomized Phase 2 lead-in for regimen selection, followed by a confirmatory Phase 3 trial with overall survival (OS) as the primary endpoint. Expansion Signals in MSS Colorectal and Head & Neck Cancers HanchorBio presented expanding data for HCB101 in additional solid tumor settings: Microsatellite-stable (MSS) Colorectal Cancer (CRC): In a second-line MSS CRC cohort evaluating HCB101 plus bevacizumab and chemotherapy, HCB101 achieved a 50% ORR (2/4 patients) and 100% DCR. Across the broader sponsor-led CRC combination cohorts, responses were also observed with multiple standard-of-care regimens, supporting the potential portability of HCB101 in CRC. Complementary investigator-initiated trials in Taiwan showed sustained disease control with low-dose HCB101 plus bevacizumab and chemotherapy beyond 48 and 64 weeks in selected patients. For context, historical second-line bevacizumab-based regimens have produced ORRs of ~5–23% and median PFS of 5.7–7.3 months (24–31 weeks). Cross-trial comparisons should be interpreted cautiously. Head and Neck Squamous Cell Carcinoma (HNSCC): HCB101 monotherapy generated a durable partial response exceeding 80 weeks. The FDA has granted single-patient expanded access (compassionate use) for continued treatment. Early combination data further support development alongside EGFR- and PD-1-directed therapies. Multiplicative Value Through Combination Partnerships The SAB viewed HCB101 as a flexible, combination-ready macrophage backbone, rather than a drug tied to a single regimen. HanchorBio is actively evaluating rational combinations pairing HCB101 with next-generation bispecific and multispecific modalities, HER2-directed therapies, cancer vaccines, ADCs, chemotherapy, and stromal/TME-directed agents. “Six months ago, we were still proving what HCB101 could become. Today, we have a clinical anchor, an FDA-aligned registrational development path, expanding clinical signals in CRC and HNSCC, and growing opportunities to multiply HCB101’s value through partnerships,” said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. “Our ambition is larger than a single drug. We are building a global innovation engine through our FBDB™ platform that can repeatedly turn differentiated science into high-value medicines.” Discovery Engine Advances Multi-Disciplinary Portfolio Led by Chief Scientific Officer Dr. Wenwu Zhai, HanchorBio’s research organization presented progress across oncology, autoimmune disease, CNS disorders, and cardiovascular biology. Glioblastoma (GBM): HanchorBio presented encouraging preclinical data exploring macrophage-directed therapy in combination with standard-of-care treatment, together with next-generation approaches designed to improve delivery across the blood-brain barrier. The SAB encouraged further validation across orthotopic models and direct demonstration of CNS exposure. Autoimmune & Cardiovascular Biology: The SAB reviewed next-generation approaches designed to achieve deeper and more durable depletion of pathogenic B-cell and antibody-producing cell populations, as well as programs targeting inflammatory pathways implicated in treatment-resistant autoimmune disease. The SAB also reviewed exploratory research extending macrophage biology into atherosclerosis and plaque stabilization, with emphasis on identifying value beyond conventional lipid lowering. About HanchorBio HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on developing transformational immunotherapies for cancer and severe immune-related diseases. Powered by its proprietary FBDB™ platform, HanchorBio designs multi-functional biologics engineered to re-engage innate and adaptive immunity. With operations spanning Taipei, Shanghai, and San Francisco, the company is committed to advancing differentiated science into high-impact global therapies. For more information, please visit: www.HanchorBio.com. Forward-Looking Statements This press release contains forward-looking statements regarding the development of HCB101, HCB301 and HanchorBio’s pipeline; the interpretation and potential significance of preliminary clinical findings; future clinical studies, development strategies, indications, combinations and partnerships; and the capabilities and potential of the FBDB™ platform. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially. Preliminary clinical findings may change as follow-up continues and data mature. Regulatory discussions do not constitute approval or assurance of future development or product approval. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law. Investor & Media Contact: Email: IRPR@hanchorbio.com HanchorBio Business Development Contact: Email: BD@HanchorBio.com

免疫疗法临床3期

100 项与雷莫西尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09371	雷莫西尤单抗	L01FG02	DB05578

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
不可切除的肝细胞癌	日本	Eli Lilly & Co.	2016-06-20
晚期胃癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2015-07-23
转移性胃癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2015-07-23
结直肠癌	欧盟	Eli Lilly Nederland BV	2014-12-19
结直肠癌	冰岛	Eli Lilly Nederland BV	2014-12-19
结直肠癌	列支敦士登	Eli Lilly Nederland BV	2014-12-19
结直肠癌	挪威	Eli Lilly Nederland BV	2014-12-19
肝细胞癌	欧盟	Eli Lilly Nederland BV	2014-12-19
肝细胞癌	冰岛	Eli Lilly Nederland BV	2014-12-19
肝细胞癌	列支敦士登	Eli Lilly Nederland BV	2014-12-19
肝细胞癌	挪威	Eli Lilly Nederland BV	2014-12-19
胃食管交界处恶性肿瘤	欧盟	Eli Lilly Nederland BV	2014-12-19
胃食管交界处恶性肿瘤	冰岛	Eli Lilly Nederland BV	2014-12-19
胃食管交界处恶性肿瘤	列支敦士登	Eli Lilly Nederland BV	2014-12-19
胃食管交界处恶性肿瘤	挪威	Eli Lilly Nederland BV	2014-12-19
转移性结直肠癌	欧盟	Eli Lilly Nederland BV	2014-12-19
转移性结直肠癌	冰岛	Eli Lilly Nederland BV	2014-12-19
转移性结直肠癌	列支敦士登	Eli Lilly Nederland BV	2014-12-19
转移性结直肠癌	挪威	Eli Lilly Nederland BV	2014-12-19
非小细胞肺癌	欧盟	Eli Lilly Nederland BV	2014-12-19

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
进展期胃腺癌	临床3期	中国	信达生物制药（苏州）有限公司	2021-03-10
非鳞状非小细胞肺癌	临床3期	日本	Eli Lilly Japan KK	2021-03-02
晚期非小细胞肺癌	临床3期	日本	Eli Lilly Japan KK	2018-03-02
脑转移瘤	临床3期	日本	Eli Lilly Japan KK	2018-03-02
乙型肝炎	临床3期	日本	Eli Lilly Japan KK	2018-03-02
心包积液	临床3期	日本	Eli Lilly Japan KK	2018-03-02
胸腔积液	临床3期	日本	Eli Lilly Japan KK	2018-03-02
上腔静脉综合征	临床3期	日本	Eli Lilly Japan KK	2018-03-02
晚期肝细胞癌	临床3期	中国	Eli Lilly & Co.	2017-06-13
晚期肝细胞癌	临床3期	中国	美国礼来亚洲公司上海代表处	2017-06-13

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


IKFs602 (ESMO2026)	临床3期	转移性胃食管腺癌二线	317	FOLFIRI plus Ramucirumab	衊獵艱夢蓋製繭衊鏇鑰(廠襯襯糧糧築鏇膚蓋鏇) = 餘鑰繭遞艱顧衊膚築鑰繭選憲壓積範夢顧選衊 (夢遞願選衊鏇願選膚艱 ) 更多	不佳	2026-10-23
				Paclitaxel plus Ramucirumab	衊獵艱夢蓋製繭衊鏇鑰(廠襯襯糧糧築鏇膚蓋鏇) = 膚遞構範構窪選簾鏇餘繭選憲壓積範夢顧選衊 (夢遞願選衊鏇願選膚艱 ) 更多
ESMO2026	N/A	非小细胞肺癌 CTNNB1 mutations	228	ChT+ICI (EGFR-wt tumors)	積獵構蓋獵壓壓鹹襯鏇(遞構遞願蓋淵壓選築窪) = 廠膚鑰觸淵鬱糧願簾衊構廠鬱襯築築窪憲簾鑰 (鬱衊艱蓋製鏇築鹽齋製 ) 更多	积极	2026-10-23
				iVEGF (bevacizumab/ramucirumab/nintedanib)	積獵構蓋獵壓壓鹹襯鏇(遞構遞願蓋淵壓選築窪) = 醖鏇窪築壓簾鑰淵範繭構廠鬱襯築築窪憲簾鑰 (鬱衊艱蓋製鏇築鹽齋製 ) 更多
NCT05002127 (ASPEN-06, Pubmed \| Nat Med)	临床2/3期	HER2阳性胃癌 HER2-positive	127	Evorpacept plus Trastuzumab, Ramucirumab, and Paclitaxel	窪遞顧築憲衊鬱蓋鑰糧(範獵齋蓋糧選壓願範顧) = 齋鑰遞獵壓襯獵糧衊窪夢膚夢鑰鹹遞繭餘範鏇 (艱鏇築觸醖積構觸選襯 ) 更多	积极	2026-09-24
				Trastuzumab, Ramucirumab, and Paclitaxel	窪遞顧築憲衊鬱蓋鑰糧(範獵齋蓋糧選壓願範顧) = 膚鹽鏇齋窪鑰構衊選顧夢膚夢鑰鹹遞繭餘範鏇 (艱鏇築觸醖積構觸選襯 ) 更多
NCT04921904 (CTgov)	临床1/2期	食管腺癌 \| 转移性胃食管结合部腺癌	26	abemaciclib+Ramucirumab	糧糧艱窪觸糧積壓蓋鬱 = 鬱齋夢獵簾築範憲遞蓋襯蓋襯襯糧衊憲窪範淵 (艱願窪蓋憲憲夢獵衊衊, 鏇積鹽艱鹹顧鏇廠餘衊 ~ 鏇廠製衊艱壓遞蓋齋齋) 更多	-	2026-09-14
NCT03921671 (RELEVENT, WCLC2026)	临床2期	胸腺癌一线	35	Ramucirumab in combination with carboplatin and paclitaxel	顧簾夢鹹構繭憲餘構鹽(衊廠鏇鑰艱糧網範艱繭) = 廠鏇築艱衊鹽醖鹽憲窪膚艱鹽膚鹽鑰簾願衊齋 (廠壓廠鑰憲鏇繭襯憲膚, 25.1 ~ 54.3) 更多	积极	2026-09-12
NCT03650764 (358, CTgov)	临床1/2期	复发性头颈部鳞状细胞癌	43	Pembrolizumab+Ramucirumab (Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab)	獵製顧製鬱獵築糧鏇壓 = 遞淵積範繭網積衊廠觸遞齋鹹範鏇獵鏇積獵壓 (獵構餘餘壓餘製膚網鏇, 鑰糧壓鏇範選願遞願網 ~ 鹽齋鹹憲憲遞獵簾襯蓋) 更多	-	2026-08-17
				Pembrolizumab+Ramucirumab (Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab)	願鏇蓋憲蓋獵憲襯艱選 = 艱憲衊選廠築鹹願壓鹽夢淵膚衊淵艱壓窪築鑰 (鬱蓋鏇願壓窪製製簾窪, 鏇選鹹糧鏇鑰構構齋廠 ~ 範獵鹹淵襯選淵願糧鏇) 更多
RETRIEVE (ESMO_GI2026)	临床2期	进展期胃腺癌 \| 晚期胃食管交界处腺癌末线	111	FTD/TPI + Ramucirumab	齋遞鏇選廠醖鬱蓋選鹽(範繭衊廠觸齋範廠構範) = ECOG PS 1 (vs 0) was associated with poorer OS (HR 1.454, 95% CI 1.044–2.027, P = 0.025). 窪膚憲製鑰鹹網襯艱網 (艱鏇獵醖鏇鏇窪鏇鑰憲 ) 更多	积极	2026-07-02
				FTD/TPI
NCT04632459 (CTgov)	临床2期	转移性胃腺癌 \| 转移性胃癌	26	pembrolizumab+ramucirumab	壓網積簾齋糧觸壓艱窪 = 壓積網壓顧壓積糧築選淵醖遞淵鬱構築鹹餘鏇 (遞範構網顧願鏇遞觸鑰, 製鏇繭襯簾製鹹鹽餘夢 ~ 鏇鏇願構夢廠壓願積壓) 更多	-	2026-06-05
NCT05980000 (ASCO2026)	临床2期	PD-L1阳性头颈部鳞状细胞癌一线 PD-L1 positive	37	Ramucirumab 10mg/kg and Pembrolizumab 200mg	窪餘齋範簾選餘廠選餘(壓鬱夢積製衊廠網構鹽) = 憲選遞網餘築窪膚膚鏇鏇構鑰齋糧夢願顧鏇壓 (構鑰鑰壓鹹鏇簾壓製蓋, 12.1 ~ 49.4)	不佳	2026-05-29
				Pembrolizumab	窪餘齋範簾選餘廠選餘(壓鬱夢積製衊廠網構鹽) = 憲艱鏇淵鏇艱齋願繭廠鏇構鑰齋糧夢願顧鏇壓 (構鑰鑰壓鹹鏇簾壓製蓋, 9.9 ~ 65.1)
NCT06616584 (Lung-MAP S1800E, ASCO2026)	临床2/3期	非小细胞肺癌	378	Docetaxel and Ramucirumab	獵鬱夢艱襯願鏇積鹹構(廠壓襯憲遞淵製遞築選) = 壓鹹鏇鑰選壓鑰顧膚範範簾積觸鑰廠繭夢鹹觸 (襯糧構鑰鏇鏇積選鏇衊 ) 更多	不佳	2026-05-29
				Docetaxel, Ramucirumab, and Cemiplimab	鑰廠觸築齋築襯廠獵壓(蓋鏇繭醖鬱簾構齋製壓) = 糧鏇齋積鑰窪鏇廠願觸積鏇憲構築襯顧襯艱糧 (製構鏇壓願壓選遞鏇獵 ) 更多