Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol

This study is for adults with locally advanced rectal cancer that has not spread to distant organs, and is classified as pMMR or MSS (which means it typically does not respond well to immunotherapy alone). The purpose is to see if a new combination of treatments given before surgery (neoadjuvant therapy) can more effectively shrink the tumor and increase the chance of curing the cancer or avoiding surgical removal of the rectum.
The main things you will do in this study are:
1. Receive a Short Course of Radiation Therapy (5 treatments over 1 week).
2. After a 1-week break, receive a combination of three drugs:
1）Nal-IRI (a special form of the chemotherapy drug Irinotecan, designed to have fewer side effects) 2）Capecitabine (a chemotherapy pill) 3）Camrelizumab (an immunotherapy drug) 3. This drug combination is given in 8 cycles, with each cycle lasting 3 weeks. 4. After finishing all cycles, the doctors will carefully check how the tumor responded.
The most important goal of this research is to see how many patients achieve a "Complete Response," which means:
1. No sign of cancer cells in the surgically removed tissue (Pathological Complete Response, pCR), or
2. No sign of cancer can be found through clinical exams, scans, and scopes, allowing the patient to avoid immediate surgery under a "Watch and Wait" strategy (Clinical Complete Response, cCR).
Researchers will also monitor:
1. The safety of the treatment and its side effects.
2. How well the cancer is controlled over time (e.g., 3-year survival without cancer recurrence).
3. The rate of successful tumor removal and the rate of preserving the anus.

开始日期2026-05-20

申办/合作机构

广东省人民医院

NCT07589244

/ Recruiting临床2/3期

A Multicenter, Open-label Phase II/III Clinical Trial of VRT106 in Combination With Camrelizumab and Apatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Immune Checkpoint Inhibitor Therapy

This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage. The phase III study will be initiated following discussions with National Medical Products Administration (NMPA) regarding the phase III protocol, based on accumulated data from phase II including safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).

开始日期2026-05-13

申办/合作机构

广州威溶特医药科技有限公司

NCT07505186

/ Not yet recruiting临床2期IIT

A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of the Combination of Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

In the management of locally advanced esophageal squamous cell carcinoma, the outcomes associated with surgical resection, whether conducted alone or supplemented with postoperative adjuvant radiotherapy and chemotherapy, have been suboptimal. Immune checkpoint inhibitors (ICIs) have shown potential in enhancing the immune system's capacity to target and eliminate cancer cells. Evidence suggests that the concurrent administration of JAK inhibitors with ICIs may improve anti-cancer efficacy, increase patient response rates, and prolong progression-free survival compared to ICIs alone. This prospective, exploratory study aims to assess the efficacy of combining camrelizumab, chemotherapy, and Ivarmacitinib in neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma, with the objective of broadening therapeutic options for this malignancy.

开始日期2026-05-01

申办/合作机构

浙江大学医学院附属第二医院（浙江省第二医院）

100 项与卡瑞利珠单抗相关的临床结果

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100 项与卡瑞利珠单抗相关的转化医学

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100 项与卡瑞利珠单抗相关的专利（医药）

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886

项与卡瑞利珠单抗相关的文献（医药）

2026-12-31·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Focused ultrasound ablation surgery combined with immune checkpoint inhibition in driver-gene wild-type NSCLC with liver metastasis: a feasibility study

Article

作者: Chen, Jinyun ; Wang, Ting ; Ouyang, Bing ; Chen, Li ; Chen, Wenzhi

BACKGROUND:

This single-arm, open-label clinical trial aimed to evaluate the preliminary safety, efficacy and feasibility of focused ultrasound ablation surgery (FUAS) sequential with immune checkpoint inhibitors (ICIs) in patients with driver-gene wild-type non-small cell lung cancer (NSCLC) and liver metastases.

MATERIALS AND METHODS:

Ten eligible patients received two cycles of FUAS sequential with ICIs. The ICIs used include Camrelizumab (7/10), Pembrolizumab (3/10) and Serplulimab used for immune rechallenge (1/10). Follow-up was conducted every 6 weeks ± 3 days, including imaging and hematological assessments. Treatment-related adverse events (AEs) were documented anytime.

RESULTS:

All participants demonstrated stable tolerability and safety in this trial. Immediate post-FUAS ablation rates ranged from 73% to 80%. The median follow-up time is 84 days (IQR, 42-127 days). From baseline to week 18, continuous shrinkage of both hepatic metastatic and target lesions was observed. The DCR of the tumor has reached 80% since the 2nd follow-up (12 weeks), and it remains at 50% until the 4th follow-up (24 weeks).

CONCLUSION:

FUAS sequential with ICIs suggests preliminary safety, activity and feasibility in treating driver-gene wild-type NSCLC patients with liver metastases, further validation is needed.

2026-05-01·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

作者: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

2026-04-13·ANTI-CANCER DRUGS

Remarkable efficacy of ivonescimab-based second-line therapy in advanced lung adenocarcinoma resistant to chemoimmunotherapy: a case report.

Article

作者: Yang, Kunning ; Wang, Xuan ; Yin, Ping

PD-1/PD-L1 inhibitors combined with chemotherapy are the current standard first-line treatment for advanced lung adenocarcinoma (LUAD). However, chemotherapy typically becomes the main therapeutic approach for subsequent treatment once the development of resistance to this initial chemoimmunotherapy, and there are limited effective treatment options available. This case report describes a 41-year-old male patient with stage IVA LUAD (PD-L1 tumor proportion score: 5%, next-generation sequencing: no mutation) who achieved a partial response (PR) with first-line camrelizumab plus pemetrexed and carboplatin, but later experienced disease progression. Upon switching to second-line therapy with ivonescimab (an anti-PD-1/vascular endothelial growth factor-A bispecific antibody) combined with docetaxel, the patient achieved a significant clinical and radiographic response, again evaluated as PR, which was sustained over 12 treatment cycles. Up to now, the progression-free survival (PFS) is more than 12 months, which is significantly longer than the 9-month PFS achieved by the first-line treatment. The regimen was well-tolerated, with only grade 1 adverse events. This case highlights the potential of ivonescimab-based therapy as an effective and manageable second-line option for patients with advanced LUAD who have progressed on prior immune checkpoint inhibitor therapy, even with low PD-L1 expression.

2,266

项与卡瑞利珠单抗相关的新闻（医药）

2026-05-22

·ioncology

瞭望前瞻丨2026年ASCO年会乳腺癌领域重磅研究进展，一文速览！

点击蓝字，关注我们编者按：2026年美国临床肿瘤学会（ASCO）年会即将于5月29日至6月2日在芝加哥盛大召开。作为全球肿瘤学领域最具影响力的学术盛会之一，本届大会将继续汇聚乳腺癌诊疗的最新前沿进展。从精准靶向治疗到免疫联合策略，从抗体药物偶联物（ADC）的深度探索到真实世界研究的实践创新，会议内容涵盖转移性、早期、局部及区域乳腺癌的众多关键议题。《肿瘤瞭望-乳腺时讯》特此整理汇总本届ASCO年会乳腺癌领域的重要进展，以飨读者。如有疏漏，欢迎指正。快速口头报告（Rapid Oral Abstract Session） Care Delivery/Models of Care 美国东部时间：5月29日2:45–4:15PM 地点：E350 摘要号：1520 英文标题：Effect of a financial navigation intervention on financial toxicity among patients with breast cancer: A randomized controlled trial in China 中文标题：金融导航干预对乳腺癌患者经济毒性影响：一项在中国开展的随机对照研究报告时间：2:45 - 4:15 PM 讲者：Weijie Xing（复旦大学附属肿瘤医院护理学院） Breast Cancer-Metastatic 美国东部时间：5月31日11：30–1:00PM 地点：Hall D1 摘要号：1013 英文标题：ASCENT-04: Analysis of efficacy by biomarker subgroups with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) 中文标题：ASCENT-04：戈沙妥珠单抗（SG）联合帕博利珠单抗（pembro）对比化疗联合帕博利珠单抗在既往未经治疗的PD-L1阳性转移性三阴性乳腺癌（mTNBC）患者中按生物标志物亚组进行的疗效分析报告时间：11:30-11:36PM 讲者：Sara M. Tolaney 摘要号：1014 英文标题：ASCENT-03: Efficacy by biomarker subgroup with sacituzumab govitecan (SG) vs chemotherapy (chemo) in participants (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors (PD-[L]1i) 中文标题：ASCENT-03：戈沙妥珠单抗（SG）对比化疗在不适合使用PD-（L）1抑制剂的既往未经治疗的晚期三阴性乳腺癌（TNBC）患者中按生物标志物亚组进行的疗效分析报告时间：11:36-11:42AM 讲者：Carlos H. Barrios 摘要号：1015 英文标题：Impact of food access and poverty on somatic genomic profiles and clinical outcomes in metastatic breast cancer 中文标题：食物获取和贫困对转移性乳腺癌体细胞基因组图谱和临床结果的影响报告时间：11:42-11:48AM 讲者：Emily L. Podany 摘要号：1016 英文标题： Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor–positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i). 中文标题：evERA BC进展后的治疗（tx）分析：一项评估giredestrant（GIRE）+依维莫司（E）治疗既往接受过CDK4/6抑制剂治疗的雌激素受体阳性、HER2阴性晚期乳腺癌（ER+, HER2- aBC）患者的III期临床试验报告时间：12:00-12:06PM 讲者：Komal L. Jhaveri 摘要号：1017 英文标题：Effectiveness of first-line ET+CDK4/6i continuation beyond disease progression in a large cohort of patients with HR+/HER2− advanced breast cancer: Results from the multicenter, real-world, Italian study PALMARES-2. 中文标题：在HR+/HER2-晚期乳腺癌大型队列患者中疾病进展后继续一线内分泌治疗（ET）+CDK4/6抑制剂的有效性：来自多中心、真实世界、意大利PALMARES-2研究的结果报告时间：12：06-12：12PM 讲者：Claudio Vernieri 摘要号：LBA1018 英文标题：Palbociclib plus tamoxifen±goserelin in women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (BC): PATHWAY, an Asian international double-blind randomized phase 3 trial—Final overall survival (OS) analysis. 中文标题：哌柏西利联合他莫昔芬±戈舍瑞林用于HR+/HER2-晚期乳腺癌女性患者：PATHWAY——一项亚洲国际双盲随机3期试验的最终总生存期分析报告时间：12:12-12:18 PM 讲者：卢彦伸（台湾大学医学院附属医院）摘要号：1019 英文标题：Paclitaxel plus bevacizumab with or without atezolizumab for hormone receptor-positive/HER2-negative advanced breast cancer: JCOG1919E (AMBITION) phase III trial. 中文标题：紫杉醇+贝伐珠单抗联合或不联合阿替利珠单抗治疗激素受体阳性/HER2阴性晚期乳腺癌：JCOG1919E（AMBITION）III期临床试验报告时间：12:30-12:36PM 讲者：Fumikata Hara 摘要号：1020 英文标题：Impact of bevacizumab on the efficacy of antibody–drug conjugates as later-line treatment of basal-like immune-suppressed triple-negative breast cancer 中文标题：贝伐珠单抗对基底样免疫抑制型三阴性乳腺癌后线抗体药物偶联物疗效的影响报告时间：12:36-12:42PM 讲者：刘引（复旦大学附属肿瘤医院）摘要号：1021 英文标题：DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P). 中文标题：DESTINY-Breast09研究分析：根据T-DXd联合帕妥珠单抗（P）的最佳缓解情况评估治疗持续时间与临床结局报告时间：12:42-12:48PM 讲者：Yeon Hee Park Breast Cancer-Local/Regional/Adjuvant 美国东部时间：6月1日9：45–11:15AM 地点：Hall D2 摘要号：508 英文标题：Adjuvant capecitabine and trastuzumab for stage IA HER2-positive breast cancer (IRIS-A): A phase II clinical trial 中文标题：卡培他滨联合曲妥珠单抗辅助治疗IA期HER2阳性乳腺癌（IRIS-A）：一项II期临床试验报告时间：9：45-9：51AM 讲者：王若曦（复旦大学附属肿瘤医院）摘要号：509 英文标题：Neoadjuvant pyrotinib vs pertuzumab therapy for HER2-positive early breast cancer: The HELEN HER-013 randomized clinical trial 中文标题：吡咯替尼对比帕妥珠单抗新辅助治疗HER2阳性早期乳腺癌：HELEN HER-013随机临床试验报告时间：9：51-9：57AM 讲者：刘真真（河南省肿瘤医院）摘要号：LBA510 英文标题： Primary results of the BETTER-CARE trial: Implementation of a needs-adapted and individualized follow-up care after primary breast cancer. 中文标题： BETTER-CARE试验的主要结果：原发性乳腺癌后实施适应需求和个体化的随访护理报告时间：9:57-10:03AM 讲者： Achim Woeckel 摘要号： 511 英文标题：The effects of Mediterranean diet, physical activity, and vitamin D on breast cancer recurrence and cardiometabolic health: A multicenter randomized trial. 中文标题：地中海饮食、体力活动和维生素D对乳腺癌复发及心脏代谢健康的影响：一项多中心随机试验报告时间：10:15-10:21AM 讲者： Livia Augustin 摘要号：512 英文标题：Effect of elinzanetant on sleep disturbance and aspects of quality of life in women with breast cancer experiencing vasomotor symptoms: OASIS-4 subgroup analysis by type of endocrine therapy. 中文标题： Elinzanetant对伴有血管舒缩症状的乳腺癌女性睡眠障碍和生活质量方面的影响：按内分泌治疗类型进行的OASIS-4亚组分析报告时间：10:21-10：27AM 讲者： Claudio Soares 摘要号：513 英文标题：Does resection of cavity shave margins impact survival in breast cancer patients? 中文标题：切除腔壁切缘是否影响乳腺癌患者的生存期？报告时间：10:27-10:33AM 讲者： Anees B. Chagpar 摘要号： LBA514 英文标题：Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial. 中文标题：新辅助rilvegostomig（R）+德曲妥珠单抗（T-DXd）治疗高危HER2阴性乳腺癌：I-SPY 2.2试验的结果报告时间：10:45-10:51AM 讲者：Ciara Catherine O'Sullivan 摘要号： LBA515 英文标题：Role of neoadjuvant versus adjuvant chemotherapy, dose density, and treatment schedule in biologically high-risk HR+/HER2- breast cancer: A pooled analysis of the WSG ADAPT-HR+/HER2- and PlanB trials. 中文标题：新辅助与辅助化疗、剂量密度及治疗方案在生物学高危HR+/HER2-乳腺癌中的作用：WSG ADAPT-HR+/HER2-和PlanB试验的汇总分析报告时间：10:51-10:57AM 讲者：Oleg Gluz 摘要号：516 英文标题：Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: Clinical and demographic risk factors of interstitial lung disease (ILD) and radiation pneumonitis (RP). 中文标题：DESTINY-Breast05中德曲妥珠单抗（T-DXd）对比恩美曲妥珠单抗（T-DM1）的次要安全性分析：间质性肺病（ILD）和放射性肺炎（RP）的临床和人口统计学危险因素报告时间：10:57-11:03AM 讲者：Michael Untch 口头报告（Oral Abstract Session） Breast Cancer—Local/Regional/Adjuvant 美国东部时间：5月30日1：15–4:15PM 地点：Hall B1 摘要号：500 英文标题：First results from the OPTIMA phase III randomized non-inferiority trial of test-directed chemotherapy in patients with high clinical risk ER-positive HER2-negative early breast cancer. 中文标题：OPTIMA Ⅲ期随机非劣效性试验初步结果：检测指导化疗在高临床风险、雌激素受体（ER）阳性/人表皮生长因子受体2（HER2）阴性早期乳腺癌患者中的应用报告时间：1:15-1:27PM 讲者： Robert C. Stein 摘要号： 501 英文标题：Prognostic and predictive impact of baseline gene expression (exp) in the NATALEE trial of adjuvant (adj) ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in HR+/HER2-early breast cancer (EBC). 中文标题：在瑞波西利+非甾体芳香化酶抑制剂（NSAI）作为辅助治疗（adj）的NATALEE试验中，基线基因表达（exp）对HR+/ HER2 -早期乳腺癌（EBC）的预后和预测影响报告时间：1:27-1:39PM 讲者： Stephen K.L. Chia 摘要号： 502 英文标题：Efficacy and safety of giredestrant (GIRE) in patients (pts) with estrogen receptor–positive, HER2-negative early breast cancer (ER+, HER2– eBC) in the phase III lidERA BC clinical trial: Results by menopausal status. 中文标题：girestrant （GIRE）治疗雌激素受体阳性、HER2阴性早期乳腺癌（ER+, HER2- eBC）患者的疗效和安全性：lidERA BC III期临床试验中绝经状态的结果报告时间：1:39-1:51PM 讲者：Peter Schmid 摘要号：LBA503 英文标题：Omission of completion axillary dissection in patients with breast cancer and sentinel lymph node macrometastases: Overall survival and patient-reported arm morbidity from the randomized SENOMAC trial. 中文标题：乳腺癌前哨淋巴结宏转移患者豁免完成性腋窝淋巴结清扫术：随机SENOMAC试验的总生存期与患者报告的手臂并发症报告时间：2:15-2:27PM 讲者：Jana de Boniface 摘要号： 504 英文标题：Surgical de-escalation of implant-based breast reconstruction (IBBR) after mastectomy for breast cancer treatment or prevention: The international randomized phase III PREPEC trial (OPBC-02). 中文标题：乳腺癌治疗或预防性乳房切除术后植入物乳房重建(IBBR)的手术降阶梯：国际随机III期PREPEC试验（OPBC-02）报告时间：2:27-2:39PM 讲者： Walter Weber 摘要号： 505 英文标题：Prediction of axillary response in 5,262 patients with node-positive breast cancer treated with neoadjuvant chemotherapy: Results from the prospective multicenter AXSANA/EUBREAST-03/AGO-B-053 study. 中文标题：5262例接受新辅助化疗的淋巴结阳性乳腺癌患者腋窝缓解的预测：前瞻性多中心AXSANA/EUBREAST-03/AGO-B-053研究结果报告时间：2：39-2:51PM 讲者： Maggie Banys-Paluchowski 摘要号：506 英文标题：Updated overall survival results from a randomized phase III trial of non-cross-resistant adjuvant chemotherapy plus endocrine therapy versus endocrine therapy alone in HR+/HER2−/lymph node-positive breast cancer with residual disease following neoadjuvant chemotherapy (NCT01019616). 中文标题：非交叉耐药辅助化疗联合内分泌治疗对比单纯内分泌治疗在HR+/HER2−/淋巴结阳性且新辅助化疗后仍有残留病灶的乳腺癌患者中的随机Ⅲ期试验：最新总生存期结果（NCT01019616）。报告时间：3:15-3:27PM 讲者：杨飏（北京大学肿瘤医院）摘要号： 507 英文标题：Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Final analysis results from the phase 3 KEYNOTE-522 study. 中文标题：新辅助帕博利珠单抗或安慰剂联合化疗序贯帕博利珠单抗或安慰剂辅助治疗高危早期TNBC：3期KEYNOTE-522研究的最终分析结果报告时间：3:27-3:39PM 讲者：Peter Schmid 摘要号：LBA660 英文标题：Anbenitamab plus albumin-bound docetaxel (nab-docetaxel) ± carboplatin (Cb) versus trastuzumab and pertuzumab plus docetaxel (THP) ± Cb as neoadjuvant therapy for HER2-positive early or locally advanced breast cancer: A randomized, open-label, multicenter, phase 3 trial. 中文标题：Anbenitamab联合白蛋白结合型多西他赛（nab-多西他赛）±卡铂（Cb）对比曲妥珠单抗和帕妥珠单抗联合多西他赛（THP）±卡铂作为HER2阳性早期或局部晚期乳腺癌新辅助治疗的随机、开放标签、多中心、Ⅲ期试验。报告时间：3:39-3:51PM 讲者：邵志敏（复旦大学附属肿瘤医院） Breast Cancer—Metastatic 美国东部时间：6月2日9:45AM - 12:45 PM 地点：Hall D1 摘要号：LBA1000 英文标题：Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab vs chemotherapy (chemo) plus pembro. 中文标题：ASCENT-04研究中对既往未经治疗的PD-L1阳性转移性三阴性乳腺癌（mTNBC）患者接受戈沙妥珠单抗（SG）联合帕博利珠单抗对比化疗联合帕博利珠单抗治疗后，下一线治疗的无进展生存期（PFS2）及后续治疗分析报告时间：9:45-9:57AM 讲者：Kevin Kalinsky 摘要号：1001 英文标题：Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-03 study of participants (pts) with previously untreated metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) vs chemotherapy (chemo). 中文标题：ASCENT-03研究中对既往未经治疗的转移性三阴性乳腺癌（mTNBC）患者接受戈沙妥珠单抗（SG）对比化疗治疗后，下一线治疗的无进展生存期（PFS2）及后续治疗分析报告时间：9:57-10:09AM 讲者：Sara A. Hurvitz 摘要号：1002 英文标题：First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study 中文标题：德达博妥单抗（Dato-DXd）对比化疗一线治疗不适合免疫治疗的局部复发不可切除或转移性三阴性乳腺癌（TNBC）患者：TROPION-Breast02 研究的额外疗效终点报告时间：10：09-10:21AM 讲者：David W. Cescon 摘要号：LBA1003 英文标题：Izalontamab brentgecan (iza-bren) versus physician’s choice of chemotherapy in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC): A randomized phase III study 中文标题：Izalontamab brentgecan（iza-bren）对比医生选择的化疗治疗不可切除的局部晚期或转移性三阴性乳腺癌（TNBC）：一项随机III期研究报告时间：10:45-10:57AM 讲者：吴炅（复旦大学附属肿瘤医院）摘要号：1004 英文标题：Prevalence of symptomatic skeletal events (SSE) with reduced denosumab (Dmab) dose density (every 12 weeks versus every 4 weeks): A randomized phase III non-inferiority trial SAKK 96/12 REDUSE. 中文标题：降低地舒单抗（Dmab）给药密度（每12周对比每4周）的症状性骨骼事件（SSE）发生率：一项随机III期非劣效性试验SAKK 96/12 REDUSE 报告时间：10:57-11:09AM 讲者： Roger Anton Fredy Von Moos 摘要号：1005 英文标题：Efficacy and safety of tucatinib (TUC) vs placebo (PBO) combined with trastuzumab and pertuzumab (HP) as maintenance therapy for HER2+ metastatic breast cancer by stratified subgroups. 中文标题：图卡替尼（TUC）对比安慰剂（PBO）联合曲妥珠单抗和帕妥珠单抗（HP）作为HER2阳性转移性乳腺癌维持治疗的分层亚组有效性与安全性分析报告时间：11:09-11:21AM 讲者：Erika P. Hamilton 摘要号：LBA1006 英文标题：Giredestrant (GIRE) + palbociclib (PALBO) vs letrozole (LET) + PALBO as first-line (1L) therapy in patients (pts) with estrogen receptor–positive, HER2-negative locally advanced or metastatic breast cancer (ER+, HER2– LA/mBC): Primary analysis of the phase III persevERA BC trial. 中文标题：Giredestrant（GIRE）联合哌柏西利（PALBO）对比来曲唑（LET）联合哌柏西利一线治疗雌激素受体阳性、HER2阴性局部晚期或转移性乳腺癌：III期persevERA BC试验的主要分析报告时间：11:45-11:57AM 讲者：Nicholas C. Turner 摘要号：LBA1007 英文标题：First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations (ESR1m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial 中文标题：一线camizestrant（CAMI）治疗晚期乳腺癌新发ESR1突变（ESR1m）：III期SERENA-6 试验的最终无进展生存期2（PFS2）报告时间：11:57-12:09PM 讲者：Francois Clement Bidard Clinical Science Symposium （临床科学研讨会） The Dr. Bernard Fisher Memorial Annual Clinical Science Symposium Supported by the Breast Cancer Research Foundation: The Future of Immunotherapy for Breast Cancer 美国东部时间：5月31日8:30 - 10:00AM 地点：Hall B1 摘要号：1009 英文标题：Efficacy and safety of camrelizumab combined with docetaxel and carboplatin as neoadjuvant therapy for triple-negative breast cancer: The HELEN-Trio 011 randomized clinical trial 中文标题：卡瑞利珠单抗 (Camrelizumab) 联合多西他赛和卡铂作为三阴性乳腺癌新辅助治疗的有效性和安全性：HELEN-Trio 011 随机临床试验报告时间：8:42-8:54AM 讲者：刘真真（河南省肿瘤医院）摘要号：1010 英文标题：Time-of-day administration of immunotherapy in early-stage triple-negative breast cancer: Immune-dependent chronotherapy effects in the phase III A-BRAVE trial. 中文标题：早期三阴性乳腺癌免疫治疗的日间给药时机：III期A-BRAVE试验中的免疫依赖性时间治疗效应报告时间：8:54-9:06AM 讲者：Maria Vittoria Dieci 摘要号：1011 英文标题：Primary results from the triple-negative cohort of TBCRC-053 (P-RAD): A randomized trial of no, low, or high dose preoperative radiation with pembrolizumab and chemotherapy in node-positive breast cancer. 中文标题：TBCRC-053 (P-RAD) 三阴性乳腺癌队列的主要结果：一项在淋巴结阳性乳腺癌中比较无、低或高剂量术前放疗联合帕博利珠单抗和化疗的随机试验报告时间：9:06-9:18AM 讲者：Alice Y. Ho 摘要号：1012 英文标题：Trastuzumab deruxtecan (T-DXd) + durvalumab (D) in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): Final analysis from DESTINY-Breast07. 中文标题：德曲妥珠单抗（T-DXd）联合度伐利尤单抗（D）治疗既往未经治疗的HER2阳性不可切除/转移性乳腺癌（mBC）患者：DESTINY-Breast07研究的最终分析报告时间：9:18-9:30AM 讲者：Sherene Loi （来源：《肿瘤瞭望》编辑部）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。

ASCO会议抗体药物偶联物临床结果

2026-05-22

·恒瑞医药

恒瑞医药“双艾”组合治疗难治性脊索瘤Ⅱ期研究荣登JCO

近日，恒瑞医药自主研发的卡瑞利珠单抗联合阿帕替尼(“双艾”组合)治疗难治性脊索瘤的前瞻性Ⅱ期临床试验，继以口头报告的形式亮相2025 ASCO[1]后，于近日正式发表于肿瘤学领域顶级期刊《Journal of Clinical Oncology》(JCO，IF=43.4)[2]。该研究由上海长征医院肖建如教授、杨诚教授团队开展，是全球首个PD-1联合抗血管生成药物治疗难治性脊索瘤的前瞻性Ⅱ期临床试验。研究显示[2]，卡瑞利珠单抗联合阿帕替尼(“双艾”组合）在晚期/难治性脊索瘤治疗中客观缓解率(ORR)高达24.2%(RECIST 1.1)，疾病控制率(DCR)达90.9%(RECIST 1.1)，中位无进展生存期(PFS)为28.4个月(RECIST 1.1)，有望为晚期脊索瘤患者带来新的治疗方案。研究发表于JCO 01 研究背景脊索瘤是一种起源于胚胎脊索残余的罕见恶性肿瘤，最常见于斜坡、骶骨和脊柱[3]。尽管其生长通常较为缓慢，但脊索瘤具有局部侵袭性行为，常浸润邻近组织[4]，被称为“沉默的侵袭者”。传统化疗对于脊索瘤的疗效有限，手术切除是目前常规的治疗方案。然而即使完整切除瘤体，仍有约50%患者会出现局部复发，5年生存率为65%-70%[5]。长期以来，难治性脊索瘤的系统治疗一直是全球骨肿瘤领域的巨大未满足的临床需求。阿帕替尼是恒瑞医药研发的一种选择性VEGFR2小分子酪氨酸激酶抑制剂，在肖建如、杨诚教授团队既往开展的阿帕替尼单药治疗晚期脊索瘤的研究中，阿帕替尼显示出临床疗效同时安全性可控[6]。卡瑞利珠单抗是恒瑞医药自主研发的高亲和力全人源化抗PD-1单克隆抗体[7]，既往已被证实在鼻咽癌、肺癌、食管癌和肝癌等领域中的疗效[8-11]。既往研究提示，抗血管生成药物和免疫检查点抑制剂联合具有协同作用，在肾癌、肝癌等多癌种延长生存期，提升缓解率，现正拓展至更多实体瘤[12,13]。抗血管生成药物加用免疫检查点抑制剂是否可以提高难治性脊索瘤患者的疗效，进一步降低患者进展风险？上海长征医院肖建如教授、杨诚教授牵头开展的这项卡瑞利珠单抗联合阿帕替尼治疗难治性脊索瘤的Ⅱ期研究给出了重要循证答案。该研究不仅有望优化脊索瘤的治疗格局，更首次提出CDKN2A作为疗效预测标志物，助力罕见骨肿瘤精准免疫治疗实现新突破。 02 研究设计该研究是一项单臂、单中心、II期临床研究。研究入组经组织学确诊为难治性脊索瘤(伴或不伴转移)且在6个月内发生疾病进展的脊索瘤患者，使用卡瑞利珠单抗(200 mg，静脉注射，每2周一次)联合阿帕替尼(250 mg/500 mg，每日交替口服)治疗，4周为一周期，直至疾病进展。研究的主要终点为ORR(RECIST 1.1)，次要终点为ORR(Choi标准评估)、无进展生存期(PFS)、总生存期(OS)、疾病控制率(DCR)和安全性。图1. 研究设计 03 研究结果 1 患者基线信息截至2025年5月31日，中位治疗时间为9个月(IQR 4.5-16.9)，中位随访时间为20.8个月(IQR 13.35-26.55)。本研究共纳入33例难治性脊索瘤患者，其中局部复发患者占69.7%，转移患者4例(占12.1%)，巨大难治性肿瘤6例(占18.2%)，有超过80%患者经历过手术治疗。 2 临床疗效结果显示，根据RECIST 1.1标准，8例患者(24.2%，[95% CI：11.1-42.3]) 达到部分缓解(PR)，22例患者(66.7%)达到疾病稳定(SD)，疾病控制率(DCR)达到90.9%(95% CI：75.7-98.1)，中位PFS为28.4个月(95%CI：13.53-43.28)。6个月PFS率为84.4%；12个月PFS率为70.0%。根据Choi标准，16例患者(48.5%，[95% CI：30.8-66.5])达到PR，11例患者(33.3%)为SD，DCR为81.8%(95% CI：64.5-93.0)，中位PFS为15.3个月(95% CI：12.5-NE)。此外，生存与疼痛方面，中位OS暂未达到，仍需更长时间的随访；疼痛评分分析结果显示，用药两个月后平均最大疼痛评分从7.36降至5.28(P＜0.001)，中位疼痛评分从4.18降至3.00(P＜0.001)。图2. 治疗疗效 3 安全性安全性方面，整体安全性可控。 4 探索性研究本研究同步采用NGS二代测序与FISH荧光原位杂交技术进行生物标志物探索，首次证实CDKN2A拷贝数缺失(CND)或纯合缺失(HD)是卡瑞利珠单抗联合阿帕替尼治疗难治性脊索瘤的强负向预后标志物；其中CDKN2A CND/HD组患者中位PFS仅4.3个月，疾病进展率高达50.0%，而非CDKN2A CND/HD组患者中位PFS尚未达到，疾病进展率为0%，两组差异极为显著。此外，研究中所有患者均为PD-L1阴性、微卫星稳定且肿瘤突变负荷偏低，进一步提示CDKN2A状态可作为更可靠的疗效预测指标，为脊索瘤精准治疗人群筛选提供关键依据。图3. CDKN2A状态与脊索瘤患者BOR之间的关联 04 研究结论本项前瞻性临床试验首次证实，卡瑞利珠单抗联合阿帕替尼在难治性脊索瘤患者中展现出令人鼓舞的抗肿瘤活性与可控的安全性，有望成为该领域的全新治疗方案。同时，研究首次明确CDKN2A基因拷贝数缺失或纯合缺失是潜在的不良预后因素，可作为疗效预测标志物用于患者分层与精准治疗选择。此外，Choi标准能够更早期、更准确地评估脊索瘤的治疗反应，可为后续临床研究与实践提供更合理的评价参考。参考文献： [1] Cheng Yang, Qi Jia, Chenglong Zhao, et al. Camrelizumab plus apatinib in patients with refractory chordoma: a single-arm, open-label, phase 2 trial.2025 ASCO Oral 11503. [2] Yang C, Jia Q, Zhao C, et al. Efficacy and Safety of Camrelizumab Plus Apatinib in Patients With Refractory Chordoma: A Phase II Clinical Trial. J Clin Oncol. Published online May 13, 2026. [3] Walcott BP, Nahed BV, Mohyeldin A, Coumans JV, Kahle KT, Ferreira MJ. Chordoma: current concepts, management, and future directions. Lancet Oncol 2012; 13(2): e69-76. [4] Stacchiotti S, Sommer J, Chordoma Global Consensus G. Building a global consensus approach to chordoma: a position paper from the medical and patient community. Lancet Oncol 2015; 16(2): e71-83. [5] Agner KE, Larkins MC. Population-based survival analysis of primary spinal chordoma in the US from 2000 to 2020. J Neurooncol 2024; 170(2): 397-405. [6] Liu C, Jia Q, Wei H, et al. Apatinib in patients with advanced chordoma: a single-arm, single-centre, phase 2 study. Lancet Oncol 2020; 21(9): 1244-52. [7] Ding X, Zhang WJ, You R, et al. Camrelizumab Plus Apatinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: An Open-Label, Single-Arm, Phase II Study. J Clin Oncol 2023; 41(14): 2571-82. [8] Zhou C,Chen G,Huang Y,et al.Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer(CameL):a randomised,open-label,multicentre,phase 3 trial.Lancet Respir. Med. 2021;9(3):305-314. doi:10.1016/S2213-2600(20)30365-9 [9] Ren S,Chen J,Xu X,et al.Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC(CameL-Sq):A Phase 3 Trial.J Thorac Oncol. 2022;17(4):544-557. doi:10.1016/j. jtho.2021.11.018 [10] Luo H,Lu J,Bai Y,et al.Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma:The ESCORT-1st Randomized Clinical Trial.JAMA.2021;326(10):916-925.doi:10.1001/jama.2021.12836 [11] Qin S,Chan SL,Gu S,et al.Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma(CARES-310):a randomised,open-label,international phase 3 study.Lancet.2023;402(10408):1133-1146.doi:10.1016/S0140-6736(23)00961-3 [12] Rini, B. I., Plimack, E. R., Stus, V., Gafanov, R., Hawkins, R., & Nosov, D., et al. (2019). Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. New England Journal of Medicine, 380(12), 1116–1127. https://doi.org/10.1056/NEJMoa1816714 [13] Finn, R. S., Qin, S., Ikeda, M., Galle, P. R., Ducreux, M., Kim, T. Y., ..., & Merle, P. (2020). Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. New England Journal of Medicine, 382(20), 1894–1905. https://doi.org/10.1056/NEJMoa1816768 声明： 1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。 2.恒瑞医药不对任何药品和/或适应症作推荐。 3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。撰稿：医学事务部肿瘤乳腺和其他肿瘤团队排版：程梦真责编：李玉莹往期精选 | 研发创新 | 恒瑞创新药艾瑞璟®获批，用于治疗复发或难治外周T细胞淋巴瘤 | 国际化 | 恒瑞医药与百时美施贵宝达成战略合作协议，携手推进肿瘤学、血液学及免疫学创新疗法创新药出海再下一城！恒瑞医药HER2 ADC瑞康曲妥珠单抗实现海外独家许可 | 重磅奖项 | 捷报！恒瑞医药创新药海曲泊帕乙醇胺片（恒曲®）专利荣获中国专利金奖喜报！恒瑞医药荣获2023年度国家科技进步奖 | 社会公益 | 恒瑞医药捐赠1000万港元，驰援香港大埔火灾救助 “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国

ASCO会议临床结果临床2期免疫疗法

2026-05-22

·和黄医药官微

和黄医药将于美国临床肿瘤学会 (ASCO) 2026年年会公布数据

中国香港、上海和美国新泽西州：2026年5月22日，星期五：和黄医药(中国)有限公司 (简称 "和黄医药" 或 "HUTCHMED") (纳斯达克/伦敦证交所: HCM; 香港交易所: 13) 今日宣布和黄医药自主研发的化合物的数项研究的最新及更新后的数据将于2026年5月29日至6月2日在美国芝加哥召开的美国临床肿瘤学会 (ASCO) 年会上公布。赛沃替尼用于治疗伴有MET扩增的胃癌或胃食道连接部腺癌患者的中国关键性II期注册研究结果将于快速口头摘要环节公布。该研究已达到主要终点，即根据RECIST 1.1标准经独立审查委员会（“IRC”）评估的客观缓解率 ("ORR")。至数据截止日2025年10月8日，IRC评估的ORR为32.3% (95%CI: 21.2%, 45.1%)，超过了预设的疗效阈值。次要终点包括IRC评估的疾病控制率 (DCR) 为63.1%，中位到达疾病缓解的时间 (TTR) 为1.4个月，中位缓解持续时间 (DoR) 为9.7个月 (95%CI: 3.7, 18.5)，以及中位无进展生存期 (PFS) 为4.0个月 (95%CI: 2.6, 5.0)。这些数据支持了向中国国家药品监督管理局提交新药上市申请，该申请已于2025年12月获受理并纳入优先审评。此外，呋喹替尼的FRESCO、FRESCO-2、FRUSICA-1和FRUSICA-2研究的进一步分析结果，以及由研究者发起的呋喹替尼和索凡替尼在多项潜在肿瘤适应症中的临床试验结果亦将于大会公布。报告详情包括已公布的摘要链接如下：公司申办的研究标题：赛沃替尼用于治疗伴有MET扩增的胃癌或胃食道连接部腺癌患者的一项II期关键性研究 A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas 报告人/主要作者：彭智，中国北京会议环节：快速口头摘要 | Rapid Oral Abstract: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：4011 时间：2026年6月1日 (星期一) 北美中部夏令时间下午1:15 标题：呋喹替尼治疗转移性结直肠癌患者的肿瘤缩小和缓解深度: FRESCO和FRESCO-2研究结果 Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 报告人/主要作者：Elena Elez，西班牙巴塞罗那会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：3555 标题：呋喹替尼联合信迪利单抗对比阿昔替尼或依维莫司在经治的晚期肾细胞癌患者中基于基线IMDC风险评分和PD-L1表达情况评估的疗效: FRUSICA-2研究的亚组分析 Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study 报告人/主要作者：杨恺惟，中国北京会议环节：海报展示 | Poster Session: Genitourinary Cancer – Kidney and Bladder 摘要编号：4531 标题：呋喹替尼联合信迪利单抗对比阿昔替尼或依维莫司在晚期肾细胞癌中的疗效: 一项基于基线肿瘤负荷的FRUSICA-2研究事后分析 Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden 报告人/主要作者：瞿元元，中国上海会议环节：海报展示 | Poster Session: Genitourinary Cancer – Kidney and Bladder 摘要编号：4533 标题：经治的pMMR子宫内膜癌患者中掌跖红肿综合征、甲状腺功能减退与临床结局的相关性: FRUSICA-1研究的亚组分析 Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1 报告人/主要作者：韩啸天，中国上海会议环节：线上发表 | Publication Only: Gynecologic Cancer 摘要编号：e17612 研究者发起的研究标题：呋喹替尼联合化疗和贝伐珠单抗联合化疗用于二线治疗转移性结直肠癌的疗效和安全性: 一项前瞻性、多中心、随机对照研究 Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial 报告人/主要作者：许剑民，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：LBA3563 标题：CONCEPT研究 (西妥昔单抗联合呋喹替尼±免疫疗法): 一项一线治疗pMMR RAS/ BRAF野生型不可切除的转移性结直肠癌的多中心、随机、开放标签的II期研究 CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer 报告人/主要作者：刘月，中国杭州会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：TPS3680 标题：呋喹替尼联合替雷利珠单抗对比曲氟尿苷/替吡嘧啶联合贝伐珠单抗用于治疗无活动性肝转移的MSS转移性结直肠癌患者的疗效: IKF-080/QUINTIS研究 Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF‑080/QUINTIS trial 报告人/主要作者：Joseph Tintelnot，德国汉堡会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：TPS3684 标题：一项评估呋喹替尼联合信迪利单抗和西达本胺用于治疗难治性MSS转移性结直肠癌的II期研究: 初步疗效和安全性 A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety 报告人/主要作者：王畅，中国长春会议环节：海报展示 | Poster Session: Developmental Therapeutics – Immunotherapy 摘要编号：2631 标题：呋喹替尼联合FOLFIRI或mFOLFOX6方案用于二线治疗RAS突变转移性结直肠癌患者: 一项II期、多中心、开放标签研究 Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study 报告人/主要作者：许贇，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：3528 标题：呋喹替尼联合卡培他滨对比卡培他滨单药作为转移性结直肠癌一线化疗后维持治疗的一项II期随机研究 A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) 报告人/主要作者：李文桦，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：3534 标题：呋喹替尼联合卡度尼利单抗用于治疗伴有肺转移的难治性MSS/pMMR结直肠癌的一项II期临床试验 A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases 报告人/主要作者：郭梦舟，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：3552 标题：免疫化疗联合或不联合呋喹替尼用于一线治疗晚期胃癌/胃食道连接部腺癌的基于生物标志物的评估: MGC-FLORA研究的初步临床结果和亚组分析 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 报告人/主要作者：朱晓东，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：4063 标题：优替德隆联合呋喹替尼治疗铂耐药复发性卵巢癌的II期临床试验 (FRUTD研究) Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) 报告人/主要作者：温灏，中国上海会议环节：海报展示 | Poster Session: Gynecologic Cancer 摘要编号：5579 标题：呋喹替尼和贝伐珠单抗联合卡培他滨交替作为转移性结直肠癌一线治疗后的维持治疗: 一项多中心、开放标签的II期研究 Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study 报告人/主要作者：廖旺军，中国广州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：e15539 标题：间歇应用呋喹替尼联合曲氟尿苷/替吡嘧啶治疗难治性转移性结直肠癌: 一项单中心、单臂II期研究 Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study 报告人/主要作者：何义富/牛佳郁，中国合肥会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：e15560 标题：伊立替康脂质体联合呋喹替尼作为转移性结直肠癌三线或后线治疗的I期研究 Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer 报告人/主要作者：黎倩，中国南宁会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：e15571 标题：西达本胺联合斯鲁利单抗和瑞戈非尼或呋喹替尼用于三线治疗晚期结直肠癌 (C‑operate/SCOG‑C001研究): 一项单臂、探索性、多中心II期临床试验 Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial 报告人/主要作者：李伟，中国苏州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：e15583 标题：呋喹替尼在美国难治性转移性结直肠癌的真实世界应用 Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States 报告人/主要作者：Vasu Bansal，美国堪萨斯城会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal 摘要编号：e15713 标题：呋喹替尼联合信迪利单抗和CAPEOX用于一线治疗晚期胃癌/胃食道连接部腺癌: 一项单臂、开放标签、多中心Ib/II期临床试验 (FUNCTION研究) Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION) 报告人/主要作者：陈贝贝，中国郑州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：e16033 标题：呋喹替尼联合卡瑞利珠单抗、紫杉醇脂质体和奈达铂用于一线治疗晚期食管鳞状细胞癌: 一项单臂II期研究的最新结果 Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study 报告人/主要作者：顾艳宏，中国南京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：e16070 标题：索凡替尼联合吉西他滨、顺铂和免疫检查点抑制剂用于治疗不可切除的局部晚期或转移性肝内胆管癌的最新结果 Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma 报告人/主要作者：石学涛/钟敬涛，中国济南会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：4136 标题：索凡替尼联合KN046和化疗用于一线治疗晚期胰腺导管腺癌: 一项Ib/II期研究的最新结果和生物标志物分析 Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial 报告人/主要作者：王文权，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：4198 标题：索凡替尼联合特瑞普利单抗用于治疗复发性卵巢透明细胞癌: 一项前瞻性单中心、单臂II期临床试验的最新进展 Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single‑arm phase II clinical trial 报告人/主要作者：杨慧娟，中国上海会议环节：海报展示 | Poster Session: Gynecologic Cancer 摘要编号：5586 标题：索凡替尼治疗晚期或转移性化疗难治性胸腺上皮肿瘤: 一项单臂、单中心II期研究 Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study 报告人/主要作者：徐蓓，中国上海会议环节：海报展示 | Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers 摘要编号：8119 标题：索凡替尼联合抗PD-1/PD-L1抗体用于二线治疗或单药用于三线治疗晚期肝细胞癌:一项单臂、开放标签、多中心II期研究 Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study 报告人/主要作者：周福祥，中国武汉会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：e16172 标题：索凡替尼联合免疫检查点抑制剂和化疗用于治疗胆管癌患者的疗效和安全性: 一项真实世界研究 Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study 报告人/主要作者：范莎莎，中国长沙会议环节：线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 摘要编号：e16222 标题：奥希替尼联合赛沃替尼用于治疗低MET基因拷贝数的奥希替尼耐药性非小细胞肺癌: 一项多中心、开放标签的II期研究 Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study 报告人/主要作者：韩翔，中国青岛会议环节：线上发表 | Publication Only: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers 摘要编号：e20079 前瞻性陈述本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对呋喹替尼、赛沃替尼和索凡替尼的治疗潜力的预期，呋喹替尼、赛沃替尼和索凡替尼的进一步临床研究计划，对呋喹替尼、赛沃替尼和索凡替尼的研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。此类风险和不确定性包括下列假设：入组率、满足研究入选和排除标准的受试者的时间和可用性；临床方案或监管要求变更；非预期不良事件或安全性问题；呋喹替尼、赛沃替尼和索凡替尼（包括作为联合疗法）达到研究的主要或次要终点的疗效；获得不同司法管辖区的监管批准及获得监管批准后获得上市许可；呋喹替尼、赛沃替尼和索凡替尼用于目标适应症的潜在市场，以及资金充足性等。此外，由于部分研究可能依赖于与其他药物联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、香港联合交易所有限公司以及AIM提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。医疗信息本新闻稿所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告，包括那些正在研发的药物。和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问：www.hutch-med.com/sc。

100 项与卡瑞利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	卡瑞利珠单抗	L01XC	DB14776

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
转移性宫颈癌	中国	苏州盛迪亚生物医药有限公司	2025-05-13
复发性宫颈癌	中国	苏州盛迪亚生物医药有限公司	2025-05-13
晚期肝细胞癌	中国	苏州盛迪亚生物医药有限公司	2023-01-31
晚期鼻咽癌	中国	苏州盛迪亚生物医药有限公司	2021-04-27
食管鳞状细胞癌	中国	苏州盛迪亚生物医药有限公司	2020-06-17
非小细胞肺癌	中国	苏州盛迪亚生物医药有限公司	2020-06-17
肝细胞癌	中国	苏州盛迪亚生物医药有限公司	2020-03-05
霍奇金淋巴瘤	中国	江苏恒瑞医药股份有限公司	2019-05-29
霍奇金淋巴瘤	中国	苏州盛迪亚生物医药有限公司	2019-05-29
非鳞状非小细胞肺癌	中国	苏州盛迪亚生物医药有限公司	-

未上市

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
转移性肝细胞癌	申请上市	美国	江苏恒瑞医药股份有限公司	2023-11-02
不可切除的肝细胞癌	申请上市	美国	江苏恒瑞医药股份有限公司	2023-11-02
鼻咽癌	申请上市	中国	苏州盛迪亚生物医药有限公司	2020-11-12
转移性胰腺癌	临床3期	中国	和黄医药（中国）有限公司	2024-05-08
口腔鳞状细胞癌	临床3期	中国	江苏恒瑞医药股份有限公司	2023-11-21
转移性三阴性乳腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2022-01-11
转移性宫颈鳞状细胞癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-07-23
局部晚期直肠癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-07-20
三阴性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2020-12-09
晚期胃食管交界处腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2020-09-21

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AACR2026	临床2期	晚期食管鳞状细胞癌二线	40	Camrelizumab + chemotherapy (Prior immunotherapy: Yes)	齋簾顧膚遞製鹽餘繭簾(膚鹹窪範築鏇積窪廠襯) = 鏇鹽蓋鏇繭遞構淵淵獵鹹憲範夢積製鹹壓餘構 (艱積製醖蓋醖憲獵餘獵, 2.13 ~ 6.8) 更多	积极	2026-04-21
				Camrelizumab + chemotherapy (Prior immunotherapy: No)	齋簾顧膚遞製鹽餘繭簾(膚鹹窪範築鏇積窪廠襯) = 簾鹹觸鹽膚構觸願顧餘鹹憲範夢積製鹹壓餘構 (艱積製醖蓋醖憲獵餘獵, 2.7 ~ 16.4) 更多
NCT04559607 (CHANCE2005, Pubmed \| J Clin Oncol)	临床2期	不可切除的肝细胞癌	200	TACE combined with camrelizumab and rivoceranib	醖衊願範餘廠鬱範夢壓(夢淵憲衊築觸夢憲繭窪) = 艱糧淵繭餘簾簾獵鏇糧襯鹹選觸壓選餘積襯築 (遞窪範壓鑰範繭鏇願醖, 8.8 ~ 13.7) 更多	积极	2026-04-10
				TACE alone	醖衊願範餘廠鬱範夢壓(夢淵憲衊築觸夢憲繭窪) = 簾願艱艱構鏇艱製夢鏇襯鹹選觸壓選餘積襯築 (遞窪範壓鑰範繭鏇願醖, 2.4 ~ 4.2) 更多
NCT04625803 (Pubmed \| NPJ Precis Oncol)	临床2期	结肠癌新辅助	12	mFOLFOX6 plus camrelizumab and apatinib	築膚構廠衊願餘獵艱鏇(衊遞醖範糧夢鹹簾鏇憲) = 壓構艱齋襯夢簾積膚簾淵觸網膚齋獵膚憲蓋憲 (鹽遞築遞衊築範膚鬱餘 ) 更多	积极	2026-04-01
ChiCTR2300068189 (ESMO_SRC2026)	临床4期	晚期肾细胞癌	21	Camrelizumab + targeted therapy	築網憲鹹醖築壓網壓鏇(顧構膚襯鏇獵網簾衊獵) = 鏇遞簾蓋鏇醖襯蓋願積製艱糧廠鑰夢鏇窪築構 (鏇廠鹽構蓋襯醖選夢製 ) 更多	积极	2026-03-09
NCT05176002 (ESOCORT-NIRT, Pubmed \| BMC Med)	临床2期	局部晚期食管鳞状细胞癌新辅助	25	Camrelizumab 200 mg + Camrelizumab 200 mgy in 23 fractions (resectable thoracic esophageal squamous cell carcinoma)	範餘壓餘鏇遞簾遞鬱艱(衊鑰積膚繭選製構蓋製) = 襯觸觸膚繭簾壓網襯襯鹽鏇艱膚夢鹽積鹽蓋艱 (網構襯鑰憲憲餘鹽獵廠 ) 更多	积极	2026-03-09
NCT03083041 (CTgov)	临床2期	晚期非小细胞肺癌	210	Apatinib+Camrelizumab (Driver Gene Negative Population)	餘積鑰構淵襯醖獵鏇憲 = 鏇選襯齋積襯選衊膚獵獵範選醖憲範繭憲襯觸 (顧獵築憲遞選窪艱鬱衊, 壓蓋艱鹹簾構窪選鏇鑰 ~ 積願觸範獵製窪選餘膚) 更多	-	2026-03-03
				Apatinib+Camrelizumab (Driver Gene Positive Population)	餘積鑰構淵襯醖獵鏇憲 = 鏇獵壓廠蓋艱構壓窪壓獵範選醖憲範繭憲襯觸 (顧獵築憲遞選窪艱鬱衊, 獵顧積製艱蓋積蓋鹽鹹 ~ 構憲鑰蓋齋齋襯選壓顧) 更多
NCT03707509 (CAPTAIN-1st, Pubmed \| JAMA Oncol)	临床3期	鼻咽癌一线	263	Camrelizumab + Gemcitabine + Cisplatin	網膚構構選鏇膚構製壓(築選鏇繭網鏇餘醖願鑰) = 築繭築醖鹽選壓繭鏇顧壓簾憲繭憲糧構觸鬱遞 (淵繭範範糧齋顧簾製顧 ) 更多	积极	2026-03-01
				Placebo + Gemcitabine + Cisplatin	網膚構構選鏇膚構製壓(築選鏇繭網鏇餘醖願鑰) = 餘製選鏇餘鹽壓鹹鹽鹹壓簾憲繭憲糧構觸鬱遞 (淵繭範範糧齋顧簾製顧 ) 更多
NCT04453826 (Pubmed \| BMJ) 人工标引	临床3期	鼻咽癌辅助	390	Camrelizumab	膚鬱窪願鏇齋壓糧廠蓋(鑰鑰壓窪鬱鏇廠願鹽鹹) = 遞簾築壓鬱淵鬱鬱顧鏇餘鑰鏇淵觸壓鹽衊鬱鬱 (廠觸醖鹽構膚衊簾壓積, 78.3 ~ 88.8) 更多	积极	2026-02-10
				Standard treatment	膚鬱窪願鏇齋壓糧廠蓋(鑰鑰壓窪鬱鏇廠願鹽鹹) = 衊鏇鏇構積憲餘鬱觸選餘鑰鏇淵觸壓鹽衊鬱鬱 (廠觸醖鹽構膚衊簾壓積, 65.2 ~ 77.9) 更多
NCT03987698 (Pubmed \| Sci Rep)	临床2期	肾细胞癌	21	Camrelizumab	願餘繭齋構鹹鬱鏇衊醖(築積夢蓋齋衊衊艱窪蓋) = 淵願鹽製壓鏇醖齋繭艱艱鏇夢遞選壓憲鹽鑰選 (衊窪築糧鏇壓範蓋網齋 ) 更多	积极	2026-02-07
				Camrelizumab + CIK cell re-transfusion	願餘繭齋構鹹鬱鏇衊醖(築積夢蓋齋衊衊艱窪蓋) = 鏇積選齋鹹繭鑰簾糧壓艱鏇夢遞選壓憲鹽鑰選 (衊窪築糧鏇壓範蓋網齋 ) 更多
NCT04295317 (ACC, Pubmed \| Lancet Gastroenterol Hepatol)	临床2期	肝内胆管癌辅助	65	CamrelizumabCapecitabine + CamrelizumabCapecitabine	襯繭觸繭構膚淵襯廠範(蓋獵鹽鹹艱襯憲構膚顧) = 積膚糧簾觸糧繭膚窪構鬱繭襯範鑰遞夢鑰遞糧 (夢觸願鏇襯願餘夢鏇觸 ) 更多	积极	2026-02-01