Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

开始日期2025-05-01

申办/合作机构

中国医科大学

NCT06914687

/ Not yet recruiting临床2期IIT

Tirellizumab Combined With SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Single-arm, Phase II Clinical Trial (Solids-03)

For peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the conversion resection rate, and may improve the long-term survival. Tislelizumab, an anti-PD-1 antibody, has recently been proved in the first- and second-line standard treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma.In the subgroup analysis of RATIONALE-305 trial, tislelizumab also showed good efficacy in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis. Combination of tirellizumab,SOX and HIPEC for peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative tirellizumab in combination with SOX and HIPEC in peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma.

开始日期2025-03-30

申办/合作机构

复旦大学

NCT06808971

/ Recruiting临床2期IIT

A Phase II Clinical Trial of Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur Gimeracil Oteracil Potassium Capsule for Perioperative Treatment of Locally Advanced Resectable Gastric/Gastroesophageal Adenocarcinoma

This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before.
After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles).
Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.

开始日期2025-02-05

申办/合作机构

中国医学科学院肿瘤医院

100 项与替吉奥相关的临床结果

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100 项与替吉奥相关的转化医学

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100 项与替吉奥相关的专利（医药）

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6,293

项与替吉奥相关的文献（医药）

2025-07-01·SEPARATION AND PURIFICATION TECHNOLOGY

Functional ionic liquid anchored TS-1 molecular sieve with multiple adsorption sites for efficient capture and separation of CO2 in flue gas systems

作者: Yuan, Maojie ; Liu, Yanduo ; Tang, Xuqi ; Guo, Xin ; An, Yongqi ; Hu, Yufeng ; Meng, Zitao ; Jiao, Jianhao ; Wang, Bingcan ; Qin, Yucai ; Li, Qiang ; Liu, Qinghua

Solid adsorption using porous mol. sieves are promising technol. to capture CO₂ from the air and industrial gases.However, the adsorption capacity and stability for most mol. sieves in complex gas systems are undesirable.The presence of alk. substances can improve the absorption capacity of materials by altering the surface properties and enhancing the interaction with CO₂.To improve the adsorption performance, we introduced amine functionalized ionic liquids (ILs) 1-aminopropyl-3-methylimidazolium bromide (APMImBr, with one amine group) and Bis-(3-aminopropyl-1-imidazole) ethylidene dibromide (BAPImEDB, with two amine group) on the surface of TS-1 mol. sieve.Under optimal exptl. conditions, APMImBr and BAPImEDB modified TS-1 mol. sieves have high adsorption capacity (increased by 148.5% and 218%, resp.) and universal adaptability and renewability.According to CO₂-TPD, XPS spectrum and quantum chem. calculations, the role of amine-based ILs can significantly enhance the weak and medium-strength basic sites, forming a multi-point alk. effect and enhancing the adsorption capacity through weak interactions (van der waals and hydrogen bonding) with CO₂.Overall, the research on multi amine functionalized ionic liquid composite solid adsorbents based on porous mol. sieves for carbon dioxide capture and recovery provides valuable insights for achieving sustainable development goals.

2025-06-01·EUROPEAN JOURNAL OF CANCER

Phase 1/2 study of liposomal irinotecan plus S-1 for metastatic pancreatic cancer refractory to gemcitabine-based treatment

Article

作者: Ueno, Makoto ; Nagano, Hiroaki ; Yamashita, Taro ; Ikeda, Masafumi ; Hisano, Terumasa ; Imaoka, Hiroshi ; Tsumura, Hidetaka ; Mitsunaga, Shuichi ; Furukawa, Takaaki ; Sasaki, Mitsuhito ; Komatsu, Yoshito ; Hamauchi, Satoshi ; Furuse, Junji ; Fukushima, Taito ; Okano, Naohiro ; Kataoka, Shigeki ; Shimizu, Satoshi ; Oshima, Kotoe ; Ozaka, Masato ; Kobayashi, Satoshi

BACKGROUND:

Liposomal irinotecan (nal-IRI) plus fluorouracil/folinic acid (5-FU/LV) improves survival in gemcitabine-refractory metastatic pancreatic cancer (PC) but requires a central venous port. S-1, an oral fluoropyrimidine with proven efficacy in PC, may replace 5-FU/LV in nal-IRI plus 5-FU/LV, potentially enhancing both convenience and antitumor effect.

METHODS:

This single-arm, open-label, phase 1/2 study included patients with histologically or cytologically confirmed adenocarcinoma, aged 20-80 years, an Eastern Cooperative Oncology Group performance status of 0-1, with metastatic disease, and refractory to gemcitabine-based treatment. The primary endpoint in phase 1 part was the frequency of dose-limiting toxicity (DLT) to nal-IRI plus S-1. The primary endpoint in phase 2 part was overall survival. This trial was registered in the Japan Registry of Clinical Trials database (jRCTs031210040).

RESULTS:

In phase 1 part, one patient with DLT was observed at nal-IRI 70 mg/m² (day 1) with S-1 80 mg/m²/day (day 1-7) in a 2-week cycle, establishing this as the recommended phase 2 dose (RP2D). Forty-nine patients from phase 1 (n = 6) and phase 2 part (n = 43) were treated with the RP2D, and their results were pooled. Median overall survival was 10.3 months (95 % confidence interval, 8.1-12.0 months). A confirmed partial response was achieved in 10 patients (20.4 %). The most frequent treatment-emergent adverse events were hypoalbuminemia (98.0 %), anemia (98.0 %), and anorexia (81.6 %). There were no treatment-related deaths.

CONCLUSIONS:

This study demonstrated that nal-IRI plus S-1 exhibited promising efficacy and an acceptable safety profile in patients with metastatic PC refractory to gemcitabine-based treatment.

2025-06-01·EJSO

Intraperitoneal paclitaxel with systemic S-1 plus oxaliplatin for advanced or recurrent gastric cancer with peritoneal metastasis: A single-arm, multicenter phase II clinical trial

Article

作者: Jang, You-Jin ; Seo, Won Jun ; Jee, Ye Seob ; Choi, Sung Il ; Oh, Sang Chul ; Lee, Chang Min ; Kim, Dong-Wook ; Kim, Jong-Han ; Park, Joong-Min ; Park, Ji Yeon ; Kim, Jong Won

BACKGROUND:

Patients with peritoneal metastasis from gastric cancer show poor prognosis with standard systemic chemotherapy. This prospective multicenter phase II clinical trial was performed to evaluate the efficacy and safety of intraperitoneal paclitaxel combined with systemic S-1 plus oxaliplatin for patients with advanced or recurrent gastric cancer with peritoneal metastasis.

PATIENT AND METHOD:

Patients with advanced or recurrent gastric cancer with histologically or radiologically confirmed peritoneal metastases were eligible for the study. The chemotherapy regimen consisted of eight cycles of intraperitoneal paclitaxel 80 mg/m² on days 1 and 8, combined with 80 mg/m² S-1 for days 1-14, and 100 mg/m² oxaliplatin on day 1, repeated every 21 days. The primary endpoint was 6-month progression-free survival. One-year progression-free and overall survival, response rate, and safety were set as the secondary endpoints.

RESULT:

In total, 28 patients were included in the study, of which 24 were analyzed, with the exception of those lost to follow-up and withdrawal of consent. The 6-months progression-free survival was 82.6 % (95 % CI: 68.5-99.6 %). The one-year progression-free and overall survival rates were 69.6 % (95 % CI: 53.1-91.2 %) and 76.9 % (95 % CI: 61-97 %), respectively. The overall response rate was 41.67 %. The hematologic toxicity profile showed grade 3/4 hematologic toxicities such as leukopenia (20.8 %), neutropenia (41.7 %), and thrombocytopenia (8.3 %). The only non-hematologic adverse event was grade 3 diarrhea. Three (12.5 %) patients experienced intraperitoneal chemoport-related adverse events.

CONCLUSION:

Bidirectional intraperitoneal paclitaxel with systemic S-1 plus oxaliplatin shows promising efficacy and safety in the treatment of peritoneal metastatic gastric cancer.

102

项与替吉奥相关的新闻（医药）

2025-04-24

·正大天晴药业集团

12项口头报告创中国药企最高纪录，正大天晴多瘤种创新管线闪耀2025ASCO

当地时间4月23日，美国临床肿瘤学会2025大会重磅揭晓中稿信息。正大天晴多瘤种创新管线再创纪录——12项口头报告（oral presentation），创下中国药企口头报告最高纪录，其中更包括4项最新重磅摘要（Late-breaking Abstract，LBA）。加上壁报和摘要收录等形式，共有40多项创新成果将在大会公布最新临床数据，展现多瘤种创新引领实力。本届 ASCO 年会将于当地时间5月30日-6月3日在美国芝加哥举办，敬请关注。12项口头报告创中国药企纪录安罗替尼、贝莫苏拜单抗、派安普利单抗、TQB2102、LM-108领衔创新产品群亮相本次大会，充分展示公司产品市场潜力。尤为值得关注的是，包括与贝莫苏拜单抗联用在内，安罗替尼此次共有9项研究入选口头报告，为国产创新药之最。LBA口头报告1.CAMPASS研究: 贝莫苏拜单抗联合安罗替尼对比帕博利珠单抗一线治疗晚期非小细胞肺癌：一项随机、单盲、多中心的III期研究#LBA8502：CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study.入选形式：LBA 口头报告通讯作者：上海市胸科医院韩宝惠第一作者：上海市胸科医院韩宝惠2.R-ALPS研究：一项贝莫苏拜单抗联合或不联合安罗替尼用于同步/序贯放化疗后未进展的局部晚期、不可切除(III期)非小细胞肺癌的巩固治疗的随机、双盲、平行对照、多中心III期临床研究#LBA8004：R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.入选形式：LBA 口头报告通讯作者：中山大学肿瘤防治中心陈明第一作者：中山大学肿瘤防治中心陈明3.STUPP方案联合或不联合安罗替尼治疗新诊断胶质母细胞瘤的疗效及安全性：一项多中心、随机、双盲的II期临床试验结果 #LBA2000：Efficacy and safety of STUPP regimen with or without anlotinib for newly diagnosed glioblastoma: Results of a multicenter, double-blind, randomized phase II trial. 入选形式：LBA 口头报告通讯作者：中山大学肿瘤防治中心陈忠平第一作者：中山大学肿瘤防治中心陈媛媛4.安罗替尼对比贝伐珠单抗联合化疗一线治疗RAS/BRAF野生型不可切除转移性结直肠癌：一项多中心、前瞻性、随机III期临床研究（ANCHOR研究）#LBA3502：Anlotinib versus Bevacizumab Added to Standard First-line chemotherapy Among Patients With RAS/BRAF Wild-type, unresectable Metastatic Colorectal cancer: A multicenter, prospective, Randomised, phase 3 Clinical Trial (ANCHOR trial)入选形式：LBA 口头报告通讯作者：浙江大学医学院附属第二医院丁克峰第一作者：浙江大学医学院附属第二医院丁克峰▲ 上下滑动查看更多口头报告1.安罗替尼联合表柔比星序贯安罗替尼维持治疗对比安慰剂联合表柔比星作为晚期软组织肉瘤（STS）一线治疗的随机、双盲、平行对照Ⅲ期研究#11501：Anlotinib in combination with epirubicin followed by maintenance anlotinib versus placebo plus epirubicin as first-line treatment for advanced soft tissue sarcoma (STS): A randomized, double-blind, parallel-controlled, phase III study.入选形式：口头报告通讯作者：复旦大学附属中山医院周宇红、北京积水潭医院牛晓辉第一作者：复旦大学附属中山医院周宇红2.贝莫苏拜单抗联合卡铂/紫杉醇方案联合或不联合安罗替尼序贯贝莫苏拜单抗联合或不联合安罗替尼维持治疗用于晚期复发子宫内膜癌的一线治疗：一项随机、开放II期临床试验#5508：Benmelstobart plus carboplatin/paclitaxel with or without anlotinib, followed by maintenance benmelstobart with or without anlotinib, as first-line treatment for advanced or recurrent endometrial cancer: A randomized, open-label, phase II trial.入选形式：口头报告通讯作者：上海市第十人民医院陈晓军第一作者：上海市第十人民医院陈晓军3.注射用TQB2102，新型双特异性抗HER2抗体偶联药物，在晚期实体瘤患者中的安全性和有效性：首次人体I期临床研究初步数据#3003：Safety and efficacy of TQB2102, a novel bispecific anti-HER2 antibody–drug conjugate, in patients with advanced solid tumors: Preliminary data from the first-in-human phase 1 trial.入选形式：口头报告通讯作者：中山大学肿瘤防治中心徐瑞华、王树森第一作者：中山大学肿瘤防治中心徐瑞华、王树森4.一项评估catequentinib hydrochloride（AL3818，盐酸安罗替尼胶囊）对比安慰剂治疗转移性或晚期平滑肌肉瘤（LMS）患者的随机 III 期临床研究#11506：A randomized phase III trial of catequentinib hydrochloride (AL3818) versus placebo in subjects with metastatic or advanced leiomyosarcoma (LMS).入选形式：口头报告通讯作者：英国皇家马斯登国民保健服务基金会信托基金和癌症研究所 Robin Jones第一作者：英国皇家马斯登国民保健服务基金会信托基金和癌症研究所 Robin Jones5.贝莫苏拜单抗联合化疗序贯联合安罗替尼一线治疗局部晚期或转移性鳞状非小细胞肺癌（sq-NSCLC）的III期临床研究#8514：Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC)入选形式：快速口头报告通讯作者：中国医学科学院肿瘤医院石远凯第一作者：中国医学科学院肿瘤医院石远凯6.艾立布林联合安罗替尼治疗晚期软组织肉瘤患者：疗效和生物标志物最新进展#11502：Eribulin plus anlotinib in advanced soft tissue sarcoma (ERAS): Updates on efficacy and biomarkers入选形式：口头报告通讯作者：四川大学华西医院姜愚第一作者：四川大学华西医院刘杰▲ 上下滑动查看更多Clinical Science Symposium1.派安普利单抗联合化疗新辅助治疗HPV阴性局部晚期头颈部鳞状细胞癌：一项II期临床试验#6011：REMATCH2201: A phase II study on reducing surcical margins in HPV-negative advanced HNSCC with neoadjuvant PD-1 inhilbitor and AP chemotherapy入选形式：Clinical Science Symposium通讯作者：华中科技大学同济医学院附属协和医院杨坤禹第一作者：华中科技大学同济医学院附属协和医院杨坤禹2.抗CCR8单克隆抗体cafelkibart（LM-108）联合抗PD-1疗法治疗胰腺癌的有效性与安全性：1/2期研究结果#4010：Efficacy and safety of cafelkibart (LM-108), an anti-CCR8 monoclonal antibody, in combination with anti-PD-1 therapy in patients with pancreatic cancer: results from phase 1/2 studies.入选形式：Clinical Science Symposium通讯作者：北京大学肿瘤医院沈琳第一作者：北京大学肿瘤医院龚继芳▲ 上下滑动查看更多多瘤种前沿创新全面开花除口头报告外，还有30多项研究覆盖肺癌、骨与软组织肉瘤、消化系统肿瘤、乳腺癌等多个瘤种，展现了正大天晴的多瘤种创新实力。（不包含口头报告）肺癌1.安罗替尼联合第三代EGFR-TKIs治疗EGFR-TKIs治疗后缓慢进展或寡进展的晚期非小细胞肺癌的回顾性研究（ALTER-L058）#8600：A retrospective study of anlotinib plus third-generation EGFR-TKIs in advanced non-small cell lung cancer with gradual or oligo progression after EGFR-TKIs treatment (ALTER-L058)入选形式：壁报通讯作者：同济大学附属上海市东方医院周彩存第一作者：同济大学附属上海市东方医院周彩存2.安罗替尼联合放疗在无法耐受同步放化疗的局部晚期非小细胞肺癌患者中的安全性与有效性：一项II期临床试验的初步结果#8043：Safety and efficacy of radiotherapy combined with anlotinib in locally advanced non-small cell lung cancer patients intolerant to concurrent chemoradiotherapy: Preliminary result of a phase II clinical trial.入选形式：壁报通讯作者：中国医学科学院肿瘤医院王健仰第一作者：中国医学科学院肿瘤医院苑雨培3.大分割放疗序贯替雷利珠单抗及安罗替尼新辅助治疗II-IIIA期非小细胞肺癌的前瞻性II期研究的初步结果#8063：Neoadjuvant hypofractionated radiotherapy plus tislelizumab with anlotinib followed by adjuvant tislelizumab with anlotinib in patients with resectable non-small cell lung cancer (NSCLC): Preliminary analysis of a phase II trial (NEO-PIONEER).入选形式：壁报通讯作者：浙江省肿瘤医院曾剑、季永领第一作者：浙江省肿瘤医院方敏▲ 上下滑动查看更多骨与软组织肉瘤安罗替尼联合吉西他滨和多西他赛治疗复发或转移性骨原发恶性肿瘤的初步结果：一项开放标签、单臂、多中心临床研究 #e23507：Preliminary results of anlotinib combined with gemcitabine and docetaxel forrecurrent or metastatic primary malignant bone tumors: an open-label, single-arm,multicenter clinical trial.入选形式：摘要收录通讯作者：中山大学附属第一医院沈靖南第一作者：中山大学附属第一医院卞艺颖消化系统肿瘤1.ALTER-E009研究更新结果：安罗替尼联合放疗治疗局部晚期或转移性食管鳞癌的有效性与安全性：一项多中心、多队列、回顾性探索研究 #e16110：Updated Results of the ALTER-E009 Study: Efficacy and Safety of Anlotinib Combined with Radiotherapy in Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC): A Multicenter, Multi-cohort Retrospective Exploratory Study入选形式：摘要收录通讯作者：山东省肿瘤医院李宝生第一作者：中国医学科学院肿瘤医院王鑫2.FAITH试验：安罗替尼联合贝莫苏拜单抗用于既往接受过免疫治疗的中晚期肝细胞癌患者的可行性与安全性：一项单臂、多中心、前瞻性II期研究 #e16225：FAITH trial: feasibility and safety of anlotinib plus benmelstobart in patients with previously immunotherapy treated intermediate-to-advanced hepatocellular carcinoma: a multicenter, single arm, prospective phase Ⅱ trial入选形式：摘要收录通讯作者：复旦大学附属中山医院孙惠川第一作者：复旦大学附属中山医院沈英皓3.ALTER-PA001：安罗替尼和贝莫苏拜单抗联合AG方案对比AG方案一线治疗转移性胰腺癌的多中心探索性临床研究#TPS4228：ALTER-PA001: A multicenter, randomized study of anlotinib and benmelstobart in combination with AG chemotherapy vs. AG as first-line treatment for metastatic pancreatic cancer入选形式：壁报通讯作者：上海交通大学医学院附属仁济医院王理伟第一作者：上海交通大学医学院附属仁济医院崔玖洁4.TQB2103，一种靶向Claudin18.2的抗体偶联药物，在晚期恶性实体瘤受试者中的首次人体 I 期临床研究#3026：First in human phase I study of TQB2103, a Claudin18.2 (CLDN18.2) targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors入选形式：壁报通讯作者：浙江省肿瘤医院程向东第一作者：浙江省肿瘤医院程向东5.TQB2868联合安罗替尼和白蛋白结合型紫杉醇/吉西他滨一线治疗转移性胰腺癌的单臂、开放II期临床研究#4159：TQB2868 combined with anlotinib and nab-paclitaxel plus gemcitabine as first-line treatment for metastatic pancreatic cancer: A prospective, multicenter, single-arm, phase 2 study入选形式：壁报通讯作者：复旦大学附属肿瘤医院虞先濬，河南省肿瘤医院陈小兵第一作者：复旦大学附属肿瘤医院施思6.安罗替尼与派安普利单抗联合GEMOX一线治疗晚期胆道癌的初步结果：一项单中心单臂探索性研究#e16195：Preliminary results of anlotinib and penpulimab (anti-PD1) combined with GEMOX in first-line treatment of advanced biliary tract cancer: A single-center, single-arm exploratory study.入选形式：摘要收录通讯作者：北京协和医院管梅第一作者：北京协和医院张智旸7.安罗替尼联合替雷利珠单抗和化疗二线治疗胰腺导管腺癌：一项探索性研究初步结果#e16394：Tislelizumab with anlotinib and chemotherapy for second-line treatment of pancreatic ductal adenocarcinoma: A phase II clinical trial.入选形式：摘要收录通讯作者：西安交通大学第一附属医院吴胤瑛第一作者：西安交通大学第一附属医院董旭媛8.安罗替尼联合贝莫苏拜单抗联合白蛋白结合型紫杉醇及顺铂一线治疗晚期胆道系统肿瘤的探索性研究#e16224：Updated results of anlotinib plus benmelstobart combined with nab-paclitaxel and cisplatin as first-line treatment for advanced biliary tract cancer: A single-arm, open-label phase II clinical trial.入选形式：摘要收录通讯作者：郑州大学第一附属医院宗红第一作者：郑州大学第一附属医院靳水玲9.恩沃利单抗联合安罗替尼及替吉奥治疗二线及以上晚期胰腺癌的疗效及安全性观察#e16385：Efficacy and safety of second-line therapy by envafolimab combined with anlotinib and S-1 in pancreatic cancer patients: A single-arm, phase II clinical trial.入选形式：摘要收录通讯作者：安徽医科大学第一附属医院张梅第一作者：安徽医科大学第一附属医院朱治法▲ 上下滑动查看更多乳腺癌1.后CDK4/6抑制剂时代的新选择：以安罗替尼为基础的联合方案治疗CDK4/6抑制剂耐药的HR阳性转移性乳腺癌的多中心真实世界研究#e13059：A New Option for post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6 Inhibitors入选形式：摘要收录通讯作者：湖南省肿瘤医院欧阳取长第一作者：湖南省肿瘤医院刘斌亮2.ETER901研究：一项评估安罗替尼联合抗 PD-L1 抗体贝莫苏拜单抗（TQB2450）对比白蛋白结合型紫杉醇作为复发或转移性三阴性乳腺癌患者一线治疗的疗效与安全性随机、开放III期临床研究#1104：ETER901: A randomized, open-label, phase III trial of anlotinib in combination with anti-PD-L1 antibody benmelstobart (TQB2450) versus nab-paclitaxel in first-line treatment of recurrent or metastatic triple-negative breast cancer.入选形式：壁报通讯作者：中国医学科学院附属肿瘤医院徐兵河第一作者：中国医学科学院附属肿瘤医院王佳玉3.TQB2102新辅助治疗在局部晚期或早期HER2阳性乳腺癌女性患者中的有效性和安全性：一项随机、开放标签、II期临床试验#591：Efficacy and safety of neoadjuvant TQB2102 in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase 2 trial入选形式：壁报通讯作者：复旦大学附属肿瘤医院邵志敏第一作者：复旦大学附属肿瘤医院李俊杰4.TQB2102在HER2低表达复发或转移性乳腺癌患者中的初步疗效与安全性：一项1b期临床研究结果#1090：Preliminary efficacy and safety of TQB2102 in patients with HER2 low-expressing recurrent/metastatic breast cancer: Results from a phase 1b study.入选形式：壁报通讯作者：中山大学肿瘤防治中心王树森，哈尔滨医科大学附属肿瘤医院张清媛第一作者：中山大学肿瘤防治中心王树森5.TQB2930，HER2双特异性抗抗体，联合化疗在既往接受过≥2线治疗的Her2阳性乳腺癌中的疗效和安全性：一项Ib/II期研究结果#1033： Efficacy and safety results of TQB2930, a HER2-targeted bispecific antibody combined with chemotherapy in patients with HER2-positive breast cancer (BC) previously treated with ≥2 line treatments: Results from a phase 1b/2 study.入选形式：壁报通讯作者：哈尔滨医科大学附属肿瘤医院张清媛第一作者：哈尔滨医科大学附属肿瘤医院张清媛6.派安普利单抗联合TP方案新辅助治疗TNBC的单臂、开放、多中心II期临床研究(neoTAPPL)#588： Neoadjuvant penpulimab combined with taxanes and carboplatin in triple-negative breast cancer: A single-arm, open-label, multi-center phase II clinical study (neoTAPPL).入选形式：壁报通讯作者：陆军军医大学第一附属医院齐晓伟第一作者：陆军军医大学第一附属医院阎文婷7.替雷利珠单抗联合安罗替尼和AT方案新辅助治疗TNBC的初步疗效和安全性#e12600：The preliminary efficacy and safety results of neoadjuvant phase II study of anlotinib plus tislelizumab combined with chemotherapy in triple-negative breast cancer.入选形式：摘要收录通讯作者：四川省人民医院罗静第一作者：四川省人民医院罗静▲ 上下滑动查看更多妇科肿瘤ALTER-GO-020试验结果：安罗替尼联合派安普利单抗一线治疗持续性、复发性或转移性宫颈癌的II期研究 #5527：A phase II study of Anlotinib plus penpulimab as first-line treatment for persistent, recurrent, or metastatic cervical cancer: Results from ALTER-GO-020 trial.入选形式：壁报通讯作者：四川省肿瘤医院张国楠第一作者：四川省肿瘤医院王登凤头颈部肿瘤1.安罗替尼新辅助治疗局部晚期分化型甲状腺癌（DTC）的有效性与安全性：一项多中心、单臂、II期研究 #6096：Efficacy and safety of anlotinib in neoadjuvant treatment of locally advanced differentiated thyroid cancer (DTC): A multicenter, single-arm, phase II study入选形式：壁报通讯作者：天津市人民医院高明第一作者：天津市肿瘤医院李大鹏2.派安普利单抗联合化疗新辅助治疗局部晚期可切除头颈部鳞状细胞癌患者的II期临床研究 #e18098：A phase II clinical study of neoadjuvant penpulimab combined with chemotherapy for patients with locoregionally advanced, resectable squamous cell carcinoma of the head and neck入选形式：摘要收录通讯作者：上海交通大学附属第九人民医院张陈平、阮敏第一作者：上海交通大学附属第九人民医院韩楠男3.Tim-3抑制剂TQB2618联合派安普利单抗和化疗一线治疗复发/转移性鼻咽癌：一项单臂，双队列，2期研究#6031：Combination of Tim-3 blockade TQB2618 with penpulimab and chemotherapy in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a single-arm, two-cohort, phase 2 study入选形式：壁报通讯作者：中山大学肿瘤防治中心马骏、蔡清清第一作者：中山大学肿瘤防治中心徐骋4.安罗替尼联合碘131治疗远处转移分化型甲状腺癌的疗效与安全性临床研究#e18133：Efficacy and safety of anlotinib combined with ¹³¹I therapy in the treatment of distant metastatic differentiated thyroid cancer: A single-arm, phase II clinical study.入选形式：摘要收录通讯作者：天津市肿瘤医院空港医院戴东第一作者：天津市肿瘤医院空港医院戴东▲ 上下滑动查看更多泌尿系统肿瘤1.贝莫苏拜单抗联合安罗替尼对比舒尼替尼一线治疗晚期肾细胞癌的III期临床研究（ETER100）的亚组分析 #4536：First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma: Subgroup analysis from the phase 3 ETER100 trial入选形式：壁报通讯作者：北京大学肿瘤医院郭军、中国医学科学院肿瘤医院周爱萍第一作者：北京大学肿瘤医院盛锡楠2.安罗替尼联合依维莫司一线治疗晚期非透明细胞肾细胞癌的1年更新结果：一项单中心、单臂II期临床研究（ALTER-UC-001）#4525：Anlotinib plus everolimus as first-line treatment for advanced non–clear cell renal cell carcinoma：1 year updated results from UC-001, a single-center, single-arm, phase II trial入选形式：壁报通讯作者：复旦大学附属肿瘤医院张海梁、叶定伟第一作者：复旦大学附属肿瘤医院徐文浩3.安罗替尼联合信迪利单抗治疗非透明细胞肾细胞癌：探索性、前瞻性多中心临床研究初步结果 #4526：Anlotinib combined with sintilimab as first-line treatment in patients with advanced non-clear cell renal cell carcinoma(nccRR): Preliminary results from an exploratory prospective multicentre clinical study入选形式：壁报通讯作者：中山大学肿瘤防治中心周芳坚第一作者：中山大学肿瘤防治中心董培▲ 上下滑动查看更多其他瘤种TQ-B3234在成人1型神经纤维瘤病（NF1）患者中的安全性、耐受性及有效性评估：一项开放的1期剂量递增与剂量扩展研究#3108：An open-label phase 1 dose-escalation and dose-expansion trial to evaluate the safety, tolerability, and efficacy of TQ-B3234 in adults with neurofibromatosis type 1(NF1)入选形式：壁报通讯作者：上海交通大学医学院附属第九人民医院李青峰第一作者：上海交通大学医学院附属第九人民医院刘珺中性粒细胞减少预防1.Guard-01：艾贝格司亭α作为同步放化疗诱导中性粒细胞减少一级预防的前瞻性研究#e24100：Guard-01: A prospective study of efbemalenograstim alfa as primary prophylaxis for concurrent chemo-radiotherapy induced neutropenia入选形式：摘要收录通讯作者：中山大学肿瘤防治中心陈明第一作者：中山大学肿瘤防治中心陈媛媛2.Guard-02：艾贝格司亭α在乳腺癌患者化疗当天预防性应用的安全性与有效性#e24088：Guard 02: Safety and efficacy of prophylactic use of novel long-acting G-CSF efbemalenograstim α on same-day of chemotherapy in Breast Cancer Patients入选形式：摘要收录通讯作者：安徽省肿瘤医院潘跃银第一作者：安徽省肿瘤医院周守兵3.Guard-03：艾贝格司亭α在发热性中性粒细胞减少（FN）中风险化疗方案伴危险因素的非小细胞肺癌患者中一/二级预防的随机、多中心、探索性临床研究#e20560：Efbemalenograstim Alfa for the Primary/Secondary Prophylaxis of Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen with Risk Factors in Patients with non-small cell lung cancer (NSCLC)：A Randomized, Multicenter, Exploratory Clinical Trial入选形式：摘要收录通讯作者：天津市肿瘤医院黄鼎智第一作者：天津市肿瘤医院李梦洁4.Guard-05：艾贝格司亭α用于卵巢癌和宫颈癌患者化疗诱导中性粒细胞减少的一级预防：一项单臂、多中心临床试验#e17556：Efbemalenograstim Alfa for Primary Prophylaxis of Chemotherapy-Induced Neutropenia In Patients With Ovarian and Cervical Cancer: A Single-Arm, Multicenter Clinical Trial入选形式：摘要收录通讯作者：山东大学齐鲁医院孔北华第一作者：山东大学齐鲁医院王丽梅▲ 上下滑动查看更多ASCO年会是全球规模最大、学术水平最高、最具权威性的临床肿瘤学会议之一。我们会持续跟进报道正大天晴在本次大会的最新资讯与核心数据，期待这些创新成果早日为肿瘤患者带来更多的生存希望和更好的治疗选择。声明：1. 本新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。2. 本公司不对任何药品和/或适应症作推荐。3. 本新闻稿中涉及的信息仅供参考，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。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。● 从“引领创新”到“投资创新” 中生引领（上海）私募投资基金揭牌成立● 应邀出席中国医学发展大会谢承润：用AI助力患者全周期健康管理，打造亚太多中心临床联盟● 中国工程院党组成员、副院长王辰院士一行到正大天晴调研 ● 双适应症申报获受理！贝莫苏拜方案“头对头”优于替雷联合化疗、覆盖Ⅲ期肺癌巩固治疗

ASCO会议临床结果临床2期临床3期

2025-04-23

·PRNewswire

Seven Oral Presentations: Innovent to Present Breakthrough Clinical Data of IBI363（PD-1/IL-2α-bias）and Other Novel Drug Candidates at the 2025 ASCO Annual Meeting

SAN FRANCISCO and SUZHOU,China, April 23, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S. Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO, further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options." Details on the abstracts are listed below: Oral Presentation 1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma Abstract Number: 2502 Session Type: Oral Abstract Session Title: Developmental Therapeutics-Immunotherapy Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT Presenter: Jun Guo, MD, Beijing Cancer Hospital 2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer Abstract Number: 104 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot" Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC) Abstract Number: 8509 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine 4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343 Abstract Number: 4017 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center 5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (ORIENT-21) Abstract Number: 7007 Session Type: Oral Abstract Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences 6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01) Abstract Number: 3519 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer-Colorectal and Anal Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT Presenter：Changqing Jing, MD, Shandong Provincial Hospital 7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in n as opharyngeal carcinoma: The EP-STAR trial Abstract Number: 6010 Session Type: Oral Abstract Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center Poster Presentation 1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress Abstract Number: TPS9594 Session Type: Poster Session Title: Melanoma/Skin Cancers Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute 2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial Abstract Number: 5565 Session Type: Poster Session Title: Gynecologic Cancer Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Jin Shu, MD, Chongqing University Cancer Hospital 3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study Abstract Number: 1029 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research 4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study Abstract Number: 1102 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Fan Wu, MD, Fujian Cancer Hospital 5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress Abstract Number: TPS4201 Session Type: Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Lin Shen, MD, Beijing Cancer Hospital 6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases. Abstract Number: 4050 Session Type: Poster Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Dan Sha, MD, Shandong Provincial Hospital *Abstracts of TYVYT ®(sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: (1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). (2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期ASCO会议免疫疗法临床结果临床2期

2025-04-21

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2025 CSCO 胃癌指南更新！看看有哪些新疗法

引言「2025 CSCO指南会」于 4 月 18 日至 19 日在山东济南正式举办，国内肿瘤领域的知名专家将齐聚一堂，以讲座和报告的形式对指南内容进行全方位解读。4 月 18 日胃癌专场，中国医科大学附属第一医院曲秀娟教授、北京大学肿瘤医院张小田教授、中山大学肿瘤防治中心王风华教授分享了胃癌综合治疗、晚期胃癌免疫治疗、晚期胃癌靶向治疗指南更新。「丁香园肿瘤时间」现将相关要点整理如下，以飨读者。 PART 01 胃癌综合治疗可手术切除胃癌的治疗更新 1 可手术切除胃癌整体治疗策略具体治疗方案推荐：更新要点：1. 删除 IVA 期胃癌推荐，将其划定为不可切除胃癌部分2. 将新辅助放化疗 + 胃切除术 D2 + 辅助化疗从 I 级推荐调整为 II 级推荐更新要点解析：1. 术前放化疗 VS. 术前化疗的 TOPGEAR 研究生存及亚组分析结果显示为阴性更新 2 可手术切除胃癌手术治疗之淋巴结清扫方式具体治疗方案推荐：更新要点：1. 删除 No.14v 清扫的 II 级推荐2. 注释更新: 进展期胃癌患者是否需要清扫肠系膜上静脉根部淋巴结组（No.14v）淋巴结存在争议。尽管有回顾性研究提示临床分期 Ⅲ～IV 期胃中、下部患者可能从 D2+No.14v 淋巴结清扫中获益，第 3 版日本胃癌诊治指南已不再将 No.14v 作为常规 D2 清扫范围，专家委员会亦认为 No.14v 可能会增加手术相关死亡风险，建议此类患者先进行新辅助治疗，若考虑清扫可能获益再行 No.14v 清扫。更新 3 可手术切除胃癌手术治疗之消化道重建部分具体治疗方案推荐：更新要点：1. 残胃胃吻合术从 II 类证据调整为 1 级推荐 (IA 类证据)2. 增加双肌瓣吻合作为 III 级推荐 (2B 类证据)3. 增加相关注释更新要点解析：1.LPPG VS. LDG 的 KLASS-04 研究结果显示：LPPG 与 LDG 术后 1 年的倾倒综合症比例分别是 13.2% 对比 15.8%，无统计学差异。LPPG 有更低的胆石发生率、血红蛋白、白蛋白保持，两者生存相当。2. 一项回顾性分析发现: 对比双通道重建，双肌瓣重建可能有更快的胃肠恢复、更早进食、更短术后住院时间，更好维持术后体重、白蛋白水平，两者术后并发症相当。更新 4 新辅助治疗-(放) 化疗部分具体治疗方案推荐：更新要点：1. 新辅助化疗 DOS 和 FLOT4 方案由 II 级推荐调整为 I 级推荐 (1B 类证据)2. 新增新辅助 SOX 方案作为食管胃结合部癌 I 级推荐 (1A 类证据)3. 新辅助放化疗由 1 级推荐调整为 II 级证据4. 注释: 新增 RESOLVE 研究 5 年随访结果。更新 5 新辅助治疗-免疫治疗部分更新要点注释 e 增加：MATTERHORN 研究、KEYNOTE-585 研究、DRAGON IV/CAP 05 研究也显示化免联合或者化靶免联合可能为 dMMR 患者带来 pCR 的提升，这部分患者的围手术期免疫治疗非常值得探索。更新要点解析：1. 纳武利尤单抗联合伊匹木单抗新辅助治疗 MSI-H/dMMR 食管胃腺癌 GERCOR NEONIPIGA 研究中:主要研究终点病理缓解（pCR）率达到了 59%。2. INFINITY 研究: 曲美木单抗 + 度伐利尤单抗新辅助治疗微卫星高度不稳定 (MSI) 可切除胃或食管胃交界部腺癌，在可评估 15 例患者 pCR 率为 9/15（60%）。3. KEYNOTE-585 研究、MATTERHORN 研究、DRAGON IV/CAP 05 研究发现免疫联合化疗在 dMMR 患者亚组带来 pCR 的提升。更新 6、术后辅助治疗部分具体治疗方案推荐：更新要点：1. 术后辅助 SOX 方案从 II 级推荐调整为 I 级推荐 (1A 类)2. 术后辅助 XELOX 方案从 I 级推荐调整为 II 级推荐 (1A 类)3. 注释: 新增 RESOLVE 研究五年随访结果更新要点解析：1.RESOLVE 研究五年随访结果显示，辅助治疗 SOX 方案的患者生存率显著高于术后接受 CapOx 方案的患者，5 年 OS 率分别为 61.0% vs.52.1% （HR = 0.77;95% CI%:0.61-0.98，p = 0.033）；围手术治疗 SOX 方案的患者也展现出比术后 CapOx 组更高的生存率，5 年 OS 率分别为 60.0% vs.52.1%（HR = 0.79,95%CI:0.62-1.00，p = 0.049)。更新 7 不可切除局部进展期胃癌-以综合治疗为主具体治疗方案推荐：更新要点：1. 明确人群为 T4b/淋巴结融合固定2. 根据 HER2/MMR 状态分层，对 HER2 高表达或 dMMR/MSI-H 病人建议强化全身治疗3. I 级推荐以系统治疗为主，兼顾系统和局部治疗4. 其他注释相应做大幅度的调整更新 8、不可切除局部进展期胃癌-以综合治疗为主更新要点：1. 增加注释 a：局部进展期不可切除胃癌兼具局部控制困难和远处转移高风险，建议此类病人提交 MDT 会诊，根据肿瘤具体侵犯程度、病理和分子分型指标（如 HER2、MMR/MSI 状态及 PD-L1 表达），全面评估肿瘤分期、综合治疗方案和转化手术的可能。一般情况良好的患者首选系统治疗，对于肿瘤明显退缩者推荐再次 MDT 评估可否手术切除; 若肿瘤仍无法切除且未发生远处转移，可考虑同步放化疗及联合免疫靶向治疗。对于不能耐受手术或放化疗以及疗中发生广泛进展、远处转移的病例，参照转移性胃癌的全身治疗选择后线方案。2. 注释 c：在免疫治疗（包括联合靶向治疗）加入系统治疗之后，一方面，术前免疫化疗联合方案显著改善了肿瘤反应，多项 II-III 期研究（包括 KEYNOTE-585、MATTERHORN、DANTE/IKF-s633、DRAGON IV/CAP 05、NEOSUMMIT-01、NCT04195828、PERSIST 研究等）中病理完全缓解 (pCR) 率 9.1%-27.9%。另一方面, 晚期胃癌一线治疗研究 KEYNOTE-859、CHECKMATE-649、ORIENT-16、GEMSTONE303、RATIONAL-305、COMPASSION15 等均证实免疫联合化疗较化疗的 ORR 提高 10-15% 左右。基于这些研究的结果，推荐化疗联合免疫治疗用于局部进展期不可切除胃癌。3. 注释 e：对于 HER2 高表达及 dMMR/MSI-H 表型的局晚不可切除胃癌，结合围手术期治疗及一线治疗研究的证据，建议采用全身治疗为主的方案。更新 9、一线治疗中增加腹膜转移分层推荐具体治疗方案推荐：更新要点：1. 在一线治疗中，增加了腹膜转移分层及推荐2. 注释增加关于腹膜转移的解释及推荐证据: 作为单一远处转移因素，不伴有其他远处部位转移，包含有、仅有腹腔细胞学阳性——CY1P0，或仅有肉眼腹膜转移——P1，或二者均存在——CY1P1。注释 t：胃癌 CY1P0 属于技术上可切除但生物学上不可切除的 IV 期病例，相比 CY0P0 患者总体预后不佳。目前对 CY1P0 患者，除非有症状需要手术治疗，否则应将全身治疗作为初始治疗。一项系统综述纳入 21 项研究和 6499 例患者，结果提示初治细胞学阳性患者经新辅助治疗后细胞学转为阴性与 OS 显著改善有关（HR = 0.64，95% CI 0.56～0.73，P<0.000 1）。一项 meta 分析结果显示，与单纯手术相比，手术联合术中腹腔化疗（intraperitoneal chemotherapy，IPC）可提高 5 年生存率 (RR = 3.10)，降低复发风险 (OR = 0.45)，在此基础上联合术中广泛腹腔灌洗（extensive intraoperative peritoneal lavage，EIPL）可使上述获益进一步增加 (相应 RR = 6.19，OR = 0.13)。小样本研究提示，CY1PO 患者接受术前 IPC 联合 D2 根治术可改善生存，但胃切除的意义和适应证仍存在争议，强调诊断性腹腔镜探查判定 CY0PO 及全身治疗为主的原则，确认无疾病进展时谨慎评估切除原发灶。总结1 可手术切除胃癌的治疗➤ 删除 IVA 期胃癌推荐，将其划定为不可切除胃癌部分➤ 将新辅助放化疗 + 胃切除数 D2 + 辅助化疗从 I 级推荐调整为 II 级推荐➤ 删除 No.14v 清扫的 II 级推荐，残胃胃吻合术从 1I 类证据调整为 I 级推荐（IA 类证据）➤ 新增: 对于 dMMR/MSI-H 型胃癌，进行新辅助免疫治疗推荐，分别作为 Ⅱ 级（PD-1 单抗联合 CTLA-4 单抗，2B 类证据）和 Ⅲ 级推荐 (PD-1 单抗联合化疗，2B 类证据)➤ 术后辅助 SOX 方案从 II 级推荐调整为 I 级推荐 (1A 类)，XELOX 方案从 I 级调整为 II 级推荐 (1A 类)2 不可手术切除局部进展期胃癌的综合治疗➤ 明确人群为 T4b/淋巴结融合固定➤ 根据 HER2/MMR 状态分层，对 HER2 高表达或 dMMR/MSI-H 病人建议强化全身治疗➤ I 级推荐以系统治疗为主，兼顾系统和局部治疗，其他注释相应做大幅度的调整3 胃癌腹膜转移的治疗➤ 在一线治疗中，增加了腹膜转移分层及推荐PART 02 晚期胃癌免疫治疗1 一线治疗中分类更新推荐意见更新要点：1.「HER2 阳性」 (IHC3+或 2+且 FISH+) 改为「HER2 高表达 (IHC3+或 2+且 FISH +)」(该部分推荐内容不变)2.「HER2 阴性」改为「HER2 中/低/不表达」3. 注释: 注释 c 中增加了「ADC 类药物的问世，打破了传统 HER2 阳性或阴性的概念，基于临床需求，可以 HER2 高表达 (IHC3+，或 2+且 FISH 阳性)、HER2 中表达 (IHC2+且 FISH 阴性)、HER2 低表达 (IHC1+，无论 FISH 状态) 或 HER2 不表达 (IHC0，无论 HER2 状态) 进行临床分类。2 HER2 中/低/不表达推荐意见更新要点：1.「HER2 阴性」改为「HER2 中/低/不表达」2. 更改帕博利珠单抗 I 级推荐的 PD-L1 表达人群:I 级推荐：从 CPS ≥ 10 分更改为 CPS > 5 分II 级推荐：CPS < 10 分更改为 CPS < 5 分或检测不可及 (1A 类证据)3. 新增无论 PD-L1 表达状态:XELOX 联合卡度尼利单抗为 I 级推荐 (1A 类证据)4. 注释 f 中增加对应 KEYNOTE-859 研究 CPS ≥ 5 分相关证据的描述。5. 新增 Claudin18.2 表达 (IHC:2-3+，≥ 75%) 的胃癌，FOLFOX/XELOX 联合佐妥营单抗为 I 级推荐 (1A 类证据)6. 增加注释: 现有数据未纳入多个标志物共过表达人群，正在开展 III 期临床研究探索针对不同靶点的不同靶向药物、免疫检查点抑制剂及化疗的联合模式，当临床实践中存在上述现象，应依据患者临床病理特征、基础疾病等综合考虑。更新要点解析：➤ 1. KN859：帕博利珠单抗 PD-L1 CPS>5 分数据，在 PD-L1 CPS>5 分患者中 mOS 为 14.0 个月和 11.5 个月 (HR = 0.70，95%CI 0.72-0.98)。➤ 2. 卡度尼利单抗 COMPASSION-15 研究结果显示，ITT 人群、PD-L1 CPS≥5 人群、PD-L1 CPS<5 人群 OS 均显示出显著疗效➤ 3. 一线治疗中增加腹膜转移分层推荐更新要点：1. 在一线治疗中，增加了腹膜转移分层及推荐2. 注释增加关于腹膜转移的解释及推荐证据更新要点解析：DRAGON-01 研究: 对于胃癌伴腹膜转移患者，腹腔内常温联合全身治疗 (NIPS) 可以显著改善 OS，且安全性可控。➤ 4. 增加序贯治疗的注释ARMANI 研究显示，在 FOLFOX 或 CAPOX 诱导治疗 3 个月后实现疾病控制的晚期 HER2 阴性胃癌或胃食管交界处 (GEJ) 癌症患者中，与继续使用 FOLFOX 相比，雷莫西尤单抗联合紫杉醇可改善无进展生存期 (PFS) 和总生存期 (OS)，但本研究未纳入中国人群，且一线治疗未含有 IO，可作为序贯药物治疗模式的参考依据。➤ 5. 二线治疗更新推荐级别注：氟尿嘧啶类包括 5-FU、卡培他滨和替吉奥dMMR/MSI-H部分Ⅰ、Ⅱ级推荐的条件：既往未用过免疫检查点抑制剂紫杉类包括紫杉醇口服溶液、白蛋白结合型紫杉醇、紫杉醇和多西紫杉醇更新要点：1.HER2 状态定义的修改，同一线2.HER2 中/低/不表达: 新增紫杉醇+呋喹替尼为 III 级推荐 (1B 类证据)3.dMMR/MSI-H，无论 HER2 状态: 帕博利珠单抗由 II 级推荐调整为 I 级推荐4. 脚注新增紫杉醇口服溶液5. 新增相关注释更新要点解析：1. 基于全球 II 期临床试验 KEYNOTE-158 和 KEYNOTE-164 的数据已获得中国国家药品监智管理局 (NMPA) 批准用于不可切除或转移性微卫显高度不稳定型 (MSI-H) 或错配修复基因缺陷型 (dMMR) 成人晚期实体癌患者；➤ 6. 新增 AK109-201 注释小样本 II 期研究结果显示，对于 PS = 0～1 分患者，二线双药化疗有效可耐受，临床实践中可经充分衡量治疗利弊后考虑。化疗联合 PD-1/PD-L1 抑制剂一线治疗失败后，二线治疗模式正在探索中，双盲随机 Ib/Ⅱ 期 I 研究 AK109-201 结果显示对于既往 PD-(L)1 抑制剂治疗失败的晚期胃癌患者，卡度尼利单抗较安感剂，联合普络西 (VEGFR2 单抗) 和紫杉醇二线治疗后，OS 及 PFS 均获得延长，III 期期确证性研究正在进行中。➤ 7. 更新注释强调精准筛选获益人群胃癌具有高度异质性及复杂免疫微环境尽管 PD-L1CPS、MMR 状态对于筛选置癌免疫获益人群有一定价值，但尚未完全满足精准治疗的临床需求。基于大样本临床研究队列动态收集外周血、组织标本、粪便标本等建立生物样本库，结合影像学等临床数据，及 HP 感染等临床病理特征，在人工智能辅助下，建立了一系列疗效预测模型或标志物或模型如外泌体 EV-score、ctDNA 动态变化 HP 感染、胃肠道微生物等，已经初步显示了重要的预测潜力，有望进一步优化免疫治疗获益人群的筛选。总结发展趋势: 前移、精准、挖掘靶点、创新策略围手术期治疗: 从近期终点到远期终点一线治疗: 治疗格局纷繁复杂二线治疗: 新格局下的填补空自三线及以上治疗: 新靶点新策略PART 03 晚期胃癌靶向治疗靶向 CLDN18.2：一线治疗更新具体治疗方案推荐：更新要点：HER2 中低或不表达，Claudin18.2 表达 (IHC:2-3+，≥75%)，FOLFOX/XELOX 联合佐妥昔单抗为 I 级推荐 (1A 类证据)更新要点解析：证据来源: 基于 SPOTLIGHT 和 GLOW 两项 III 期临床研究结果显示，佐妥昔单抗联合化疗一线治疗 CLDN18.2 阳性胃癌可显著延长患者 mPFS 和 mOS。Claudin 18.2 表达检测更新具体治疗方案推荐：注释 i：Claudin 18.2 检测采用免疫组化方法，其高表达判读标准多基于临床试验制定的阈值体系。高表达定义需同时满足以下特征：①肿瘤细胞呈现完整、基底、顶膜、外侧膜染色 (排除细胞胞质染色)；②染色强度 (≥2+/中-强表达) 及阳性细胞比例达到预设阈值。由于缺乏统一标准，现有临床研究中高表达阈值存在差异:Mono 研究采用 ≥ 50% 肿瘤细胞中等或强膜染色；FAST 研究定义为 240% 肿瘤细胞 2+或 3+膜染色; 而 Spolight、GLOW 研究：基于自动化检测平台，阈值定为 ≥ 75% 肿瘤细胞呈现中-强膜染色。临床实践中建议优先采用经临床试验验证的标准化检测方案，阈值参考检测系统、抗体克隆号及临床试验结果。更新要点：1.Claudin 18.2 表达检测由 2024 版的 II 级推荐 (2A 类) 升级为 I 级推荐 (1B 类)2. 新增 EBV 状态和 FGFR2b 检测为 III 级推荐3. 注释新增 CLDN18.2，FGFR2b 及 EBV 检测的描述靶向 VEGFR：二线治疗更新具体治疗方案推荐：注：氟尿嘧啶类包括 5-FU、卡培他滨和替吉奥dMMR/MSI-H部分Ⅰ、Ⅱ级推荐的条件：既往未用过免疫检查点抑制剂紫杉类包括紫杉醇口服溶液、白蛋白结合型紫杉醇、紫杉醇和多西紫杉醇更新要点：1.HER2 状态定义的修改，同一线2.HER2 阴性: 新增紫杉醇 + 呋喹替尼为 I 级推荐 (1B 类证据)3. 脚注新增紫杉醇口服溶液更新要点解析：1. 证据来源: 基于 FRUTIGA II 期临床研究结果显示，紫杉醇+呋喹替尼二线治疗非 HER2 高表达人群可显著改善患者的获益，延长中位 PFS（5.6 个月 vs 2.7 个月，HR = 0.57，P < 0.0001）、提高 ORR（42.5% vs 22.4%，P < 0.0001）和 DCR（77.2% vs 56.3%，P < 0.0001）2. 2024 年 9 月获 NMPA 批准紫杉醇口服溶液用于一线合氟尿嘧啶类方案治疗期间或治疗后出现疾病进展的晚期胃癌患者的治疗。靶向 HER2：附录新增胃病 HER2 状态及定义具体治疗方案推荐：备注：高表达，等同于根据 ToGA 研究确定的「HER2 阳性」标准。病埋科对于胃癌 HER2 检测标本的免疫组化 (IHC) 和原位杂交 (ISH) 检测结果的判读与评分标准，仍遵循中国临床肿瘤学会 (CSCO) 指南以及美国病理学家学会 (CAP) 所制定的 HER2 检测标准; 此次仅对 HER2 分类命名作更新，旨在结合当前临床药物的最新进展，进一步优化分类体系。这将有助于未来针对更多抗 HER2 药物的精准治疗策略制定。靶向 HER2 一线治疗更新：HER2 相关表述改变具体治疗方案推荐：更新要点：1.「HER2 阳性 (IHC3+或 2+且 FISH+)」表述改为「HER2 高表达 (IHC3+或 2+且 FISH+)」(该部分推荐内容不变)；2.「HER2 阴性」表述改为「HER2 中低或不表达」靶向 HER2：三线及三线以上治疗更新具体治疗方案推荐：注: 既往未用过免疫检查点抑制剂1.HER2 状态定义的修改，同一线2. HER2 高表达人群，德曲妥珠单抗升级为 I 级推荐 (1B 类证据)3. HER2 中表达人群，推荐维迪西妥单抗 (2A 类证据)4. 删除 HER2 高表达人群阿帕替尼和纳武利尤单抗 I 级推荐增加注释 X: 尽管推动阿帕替尼与纳武利尤单抗获批适应证的两项 III 期研究均未将 HER2 高表达患者作为排除标准，但随着 ADC 类抗 HER2 治疗新药物获得三线适应证，原则上仅在 HER2 低表达或不表达人群中考虑阿帕替尼及纳武利尤单抗更新要点：1. 证据来源: 中国注册桥接研究 DESTINY-Gastric06 研究结果。T-DXd 敏感性分析的 mOS 达 11.1 个月，取得了与 DG01 研究一致性的生存获益。总结（红色为新增调整部分）一线治疗曲妥珠单抗一线治疗佐妥昔单抗一线治疗 (1A 类，I 级推荐)二线治疗雷莫西尤单抗二线治疗呋喹替尼二线治疗 (1B 类，Ⅲ 级推荐)三线治疗维迪西妥单抗三线治疗德曲妥珠单抗三线治疗 (1B 类，I 级推荐)阿帕替尼三线治疗➤ 佐妥昔单抗联合化疗一线治疗适应症的全球获批和指南的推荐，CLDN18.2 成为第二个确立的指导晚期胃癌靶向治疗的靶点，晚期胃癌一线精准治疗迎来新的格局；➤ 抗 HER2-ADC 作为一线曲妥珠治疗耐药后二线及后线的选择，将晚期胃抗 HER2 治疗带入全程抗 HER2 时代，为患者带来生存获益最大化；➤ 靶向免疫化疗时代，不同药物人群精准选择、不同联合策略及优势人群富集耐药克服等关注，期待更多确证性研究结果指导晚期胃癌抗肿瘤药物个体化的排兵布阵；➤ 作为伴随诊断，就 HER2 或 CLDN 18.2 等表达精准指导、不同机制靶向药物的获益人群定义及选择、检测新技术的更新等临床对病理提出更高要求和加强临理之间对话与合作。本文首发于丁香园旗下专业平台：丁香园肿瘤时间整理：毛阳；编辑：Bree题图：图虫创意投稿：sunjiamei@dxy.cn

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适应症	国家/地区	公司	日期
HR阳性/HER2阳性乳腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2022-11-24
HR阳性/HER2阴性乳腺癌	日本	OKAYAMA TAIHO Pharmaceutical Co., Ltd.	2017-02-15
晚期胃癌	欧盟	Nordic Group BV	2011-03-14
晚期胃癌	冰岛	Nordic Group BV	2011-03-14
晚期胃癌	列支敦士登	Nordic Group BV	2011-03-14
晚期胃癌	挪威	Nordic Group BV	2011-03-14
转移性结直肠癌	欧盟	Nordic Group BV	2011-03-14
转移性结直肠癌	冰岛	Nordic Group BV	2011-03-14
转移性结直肠癌	列支敦士登	Nordic Group BV	2011-03-14
转移性结直肠癌	挪威	Nordic Group BV	2011-03-14
胃癌	中国	山东新时代药业有限公司	2008-12-19
胆道癌	日本	Taiho Pharmaceutical Co., Ltd.	2007-08-23
胰腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2006-08-10
乳腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2005-11-14
非小细胞肺癌	日本	Taiho Pharmaceutical Co., Ltd.	2004-12-14
结直肠癌	日本	Taiho Pharmaceutical Co., Ltd.	2003-12-17
头颈部肿瘤	日本	Taiho Pharmaceutical Co., Ltd.	2001-04-04

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适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处癌	临床3期	美国	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	阿根廷	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	比利时	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	巴西	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	保加利亚	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	克罗地亚	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	爱沙尼亚	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	德国	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	匈牙利	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	以色列	Taiho Oncology, Inc.	2011-04-14

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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


JPRN-jRCTs031180006 (JCOG1301C \| Trigger, ASCO_GI2025) 人工标引	临床2期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌辅助 HER2 Positive	46	S-1/cisplatin	鑰夢鹹積願齋網鹹衊鑰(鑰鹽簾獵膚繭淵選鏇艱) = 艱繭選遞餘艱窪齋廠淵觸壓鑰齋繭衊簾製夢襯 (積範鏇繭齋構窪鹽艱鏇 ) 更多	积极	2025-01-23
				S-1/cisplatin + Trastuzumab	鑰夢鹹積願齋網鹹衊鑰(鑰鹽簾獵膚繭淵選鏇艱) = 顧鏇願鑰構鏇糧積壓憲觸壓鑰齋繭衊簾製夢襯 (積範鏇繭齋構窪鹽艱鏇 ) 更多
NCT04999332 (ASCO_GI2025)	临床2期	局部晚期胃食管交界处腺癌	-	Leucovorin, Oxaliplatin, Docetaxel, S-1 (LOTS)	製餘鏇糧壓構範築網積(鹹獵齋繭鹹窪選蓋範網) = 憲網簾繭齋鹽壓襯艱齋構醖窪顧範遞鑰齋製艱 (膚製鏇襯構繭觸醖觸窪 ) 更多	积极	2025-01-23
				5-fluorouracil, Oxaliplatin, Docetaxel, Leucovorin (FLOT)	製餘鏇糧壓構範築網積(鹹獵齋繭鹹窪選蓋範網) = 觸築壓醖鏇壓願觸範鏇構醖窪顧範遞鑰齋製艱 (膚製鏇襯構繭觸醖觸窪 ) 更多
ASCO_GI2025	N/A	胰腺癌辅助	129	S-1 (Induction within 2 weeks after surgery)	積顧鹽積醖淵夢鏇製衊(淵壓鬱憲鹽膚衊築糧鹽) = 艱繭鏇壓鬱衊築廠繭襯壓網築願艱膚醖遞鑰窪 (鏇鑰鹽廠襯簾範製觸鹽 ) 更多	积极	2025-01-23
				S-1 (Induction within 3-6 weeks after surgery)	積顧鹽積醖淵夢鏇製衊(淵壓鬱憲鹽膚衊築糧鹽) = 窪蓋繭顧蓋鹽網鏇觸繭壓網築願艱膚醖遞鑰窪 (鏇鑰鹽廠襯簾範製觸鹽 ) 更多
NCT04999332 (ESMO_ASIA2024) 人工标引	临床2期	局部晚期胃食管交界处腺癌 \| 局部晚期胃癌	46	Leucovorin, Oxaliplatin, Docetaxel, S-1 (LOTS)	觸鏇獵壓淵鹽鹹艱願壓(襯觸鏇積繭衊觸蓋糧鹹) = 構鏇範鏇製艱鏇觸構醖糧鹽構膚簾繭獵淵淵網 (觸鹽簾齋製膚廠齋選醖 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	胃癌辅助	73	Completion group (S-1 chemotherapy for 1 year)	製夢繭艱鬱鑰艱選積襯(窪製餘艱壓鏇鬱鬱簾鑰) = 壓繭選製襯獵膚糧製構窪觸窪鹹鏇衊鏇壓製範 (範淵醖積製壓蓋淵壓醖 ) 更多	不佳	2024-12-07
				Non-completion group (did not complete S-1 chemotherapy)	築襯築顧糧鑰範願獵簾(衊鬱願鹹艱鹹壓簾夢鏇) = 淵齋夢鏇壓範窪衊淵獵襯淵製遞觸糧網獵鏇顧 (築窪餘齋範鹹蓋範鹽構 ) 更多
NCT05026905 (TCOG T5221, ESMO2024) 人工标引	临床2期	胰腺癌一线	50	GASL (Gemcitabine plus nab-paclitaxel and S-1/leucovorin	構構鑰膚範壓夢襯願網(壓鏇繭繭廠鹹顧膚鑰繭) = 觸範鑰壓願餘繭網襯構衊糧獵鏇齋築鹽淵鹽鏇 (鏇鏇鏇遞簾網廠壓鬱醖 ) 更多	积极	2024-09-16
				GAP (Gemcitabine plus nab-paclitaxel and oxaliplatin)	構構鑰膚範壓夢襯願網(壓鏇繭繭廠鹹顧膚鑰繭) = 餘構餘衊願廠襯觸窪鏇衊糧獵鏇齋築鹽淵鹽鏇 (鏇鏇鏇遞簾網廠壓鬱醖 ) 更多
ESMO2024 人工标引	临床1/2期	转移性胰腺癌二线	120	S-1 and liposomal irinotecan (nal-IRI)	觸衊鏇構壓窪窪鏇顧蓋(鏇糧願膚顧衊衊鬱衊齋) = 蓋艱網憲顧衊蓋鬱餘構構餘鑰構淵繭鏇襯衊襯 (廠餘製鹹鹽鬱鹹壓憲範 ) 更多	不佳	2024-09-16
				5-fluorouracil5-fluorouracil/leucovorin (5-FU/LV) and nal-IRI	觸衊鏇構壓窪窪鏇顧蓋(鏇糧願膚顧衊衊鬱衊齋) = 衊衊築夢蓋構蓋獵鑰廠構餘鑰構淵繭鏇襯衊襯 (廠餘製鹹鹽鬱鹹壓憲範 ) 更多
NCT03636308 (Pubmed) 人工标引	临床2期	胰腺癌一线	62	nab-paclitaxel plus S-1 (AS)	憲醖蓋餘餘製膚膚糧鑰(遞膚憲憲製獵壓簾築襯) = 製衊簾齋選觸窪鬱網糧鹹範糧簾襯膚積窪繭醖 (餘構繭範餘範網繭鑰齋 ) 更多	积极	2024-07-11
				nab-paclitaxel plus gemcitabine (AG)	憲醖蓋餘餘製膚膚糧鑰(遞膚憲憲製獵壓簾築襯) = 壓願願廠製衊選憲窪齋鹹範糧簾襯膚積窪繭醖 (餘構繭範餘範網繭鑰齋 ) 更多
NCT03162510 (TCOG T1216, Pubmed) 人工标引	临床1期	胃肠道肿瘤	-	nab-paclitaxeloxaliplatinS-1	獵糧憲窪獵蓋衊願選願(簾範鹽鹹餘構顧鹹選觸) = 鏇網窪鏇鑰蓋窪醖壓醖蓋鬱遞鹹糧鏇積窪選憲 (鏇蓋簾淵膚網醖繭製糧 ) 更多	积极	2024-06-21
JPRN-UMIN000026858 (GABARNANCE, ASCO2024) 人工标引	临床2/3期	胰腺癌新辅助	112	Gemcitabine+nab-paclitaxel	糧製構範觸蓋襯鬱願構(憲餘築觸鹹艱齋製積膚) = 蓋醖餘顧鹹選糧壓顧網築鏇鏇憲廠範築窪築構 (構選獵簾襯蓋廠壓鑰築 ) 更多	积极	2024-06-02
				Concurrent chemoradiotherapy+S-1	糧製構範觸蓋襯鬱願構(憲餘築觸鹹艱齋製積膚) = 觸餘鑰鑰網願鑰構鑰願築鏇鏇憲廠範築窪築構 (構選獵簾襯蓋廠壓鑰築 ) 更多