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Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma (G/GEJ)

2026年7月8日 更新者：Akeso

A Randomized, Double-blind, Multi-regional Phase 3 Study of Cadonilimab Combined With Chemotherapy Versus Chemotherapy in Combination With or Without Nivolumab for the First-line Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

900

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Yelena Janjigian, MD

学习地点

  • 中国
      • Beijing、中国
        • Beijing Friendship hospital, Capital Medical University
        • 接触：
          • Wei Deng, MD
      • Beijing、中国
        • Peking University Cancer Hospital, Gastrointestinal Cancer Center I
        • 接触：
          • Jiafu Ji, MD
      • Beijing、中国
        • Peking University Cancer Hospital, Gastrointestinal Oncology
        • 接触：
          • Lin Shen, MD
      • Guangzhou、中国
        • Guangdong Provincial People's Hospital
        • 接触：
          • Jian Xiao, MD
      • Shanghai、中国
        • Zhongshan Hospital Fudan University
        • 接触：
          • Xuefei Wang, MD
  • 德国
      • Frankfurt、德国
        • University Cancer Center Frankfurt
        • 接触：
          • Thorsten O Goetze, MD
      • Mainz、德国
        • Universitätsmedizin der Johannes Gutenberg-Universität
        • 接触：
          • Markus Mohler, MD
      • Marburg、德国
        • Univerity Marburg
    • North Rhine-Westphalia
      • Essen、North Rhine-Westphalia、德国
        • Universitaetsklinikum Essen
        • 接触：
          • Isabel Virchow, MD
  • 波兰
      • Krakow、波兰
        • Pratia MCM Krakow
      • Poznan、波兰
        • Pratia Poznań
        • 接触：
          • Piotr Tomczak, MD
      • Warsaw、波兰
        • Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie
        • 接触：
          • Lucjan S Wyrwicz, MD
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85054
        • Mayo Clinic
        • 接触：
          • Ashish Chintakuntlawar,
    • California
      • Los Angeles、California、美国、90095
        • UCLA Health
        • 接触：
          • Randy Hecht, MD
    • Colorado
      • Denver、Colorado、美国、80218
        • Rocky Mountain Cancer Centers
        • 接触：
          • Allen L Cohn, MD
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale School of Medicine
        • 接触：
          • Raghav Sundar, MD
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Health
        • 接触：
          • Zaid AI-Saheli, MD
    • New York
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
      • New York、New York、美国、10029
        • Mount Sinai
        • 接触：
          • Deirdre Cohen, MD
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University
        • 接触：
          • Emerson Chen, MD
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • Sarah Cannon Research Institute (SCRI) - Oncology Partners
        • 接触：
          • David R Spigel, MD
    • Texas
      • Dallas、Texas、美国、75246
        • Baylor Scott & White Health
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center
        • 接触：
          • Jaffer A. Ajani,, MD
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • University of Wisconsin Carbone Cancer Center
        • 接触：
          • Nataliya Uboha, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Able to provide written informed consent and can understand and comply with the requirements of the study.
  2. Histopathologically-confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma.
  3. No prior systemic therapy for locally advanced unresectable or metastatic G/GEJ adenocarcinoma. NOTE: For participants who have received prior neoadjuvant/adjuvant therapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
  4. ECOG PS of 0 or 1 within 3 days prior to randomization.
  5. Age ≥ 18 years at the time of voluntarily signing informed consent.
  6. Evaluable PD-L1 expression results.
  7. Participants must have at least one measurable lesion per RECIST v1.1 as assessed by investigator assessment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  8. Adequate organ function as indicated by the following laboratory values. Specimens must be collected within 7 days prior to the first dose of study treatment.
  9. Life expectancy ≥3 months.
  10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during treatment, and for at least 150 days after the last dose of cadonilimab/nivolumab, 270 days after the last dose of oxaliplatin, and 180 days after the last dose of capecitabine.
  11. Non-sterile males must agree to use effective contraception during treatment and for at least 120 days following the last dose of cadonilimab/nivolumab/capecitabine and 180 days after the last dose of oxaliplatin.

Exclusion Criteria:

  1. Histopathologically confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma.
  2. Known HER2 positive. Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH).
  3. Participants with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1 time/month).
  5. Clinically significant bleeding symptoms within 28 days before the first dose or a definite tendency to bleed.
  6. Have a history of ≥ Grade 2 gastrointestinal perforation and/or fistulae (including prior gastric fistula operation) within 6 months prior to randomization.
  7. Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Cadonilimab/placebo+CAPOX
Cadonilimab/placebo in combination with oxaliplatin and capecitabine (CAPOX)
药品：安慰剂
安慰剂
药品：Cadonilimab
抗PD-1/ CTLA-4四聚体双特异性抗体
药品：CAPOX regimen
A combination treatment contains oxaliplatin and capecitabine
有源比较器：CAPOX±nivolumab/placebo
Oxaliplatin and capecitabine with or without nivolumab (CAPOX)
药品：安慰剂
安慰剂
药品：CAPOX regimen
A combination treatment contains oxaliplatin and capecitabine
药品：Nivolumab
Anti-PD-1 monoclonal antibody

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall survival (OS)
大体时间：Approximately up to 14months
Time from randomization to death from any cause
Approximately up to 14months

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival(PFS)
大体时间：Approximately up to 8 months
Time from the date of randomization to the date of progressive disease or death from any cause, whichever occurs first.
Approximately up to 8 months
Objective response rate (ORR)
大体时间：Approximately up to 8 months
Approximately up to 8 months
Disease control rate (DCR)
大体时间：Approximately up to 8 months
Approximately up to 8 months
Duration of response (DoR)
大体时间：Approximately up to 8 months
Approximately up to 8 months
Safety assessment
大体时间：Approximately up to 18 months
Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Approximately up to 18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Akeso

调查人员

  • 首席研究员：Jiafu Ji, MD、Peking University Cancer Hospital, Beijing, Beijing 100142, China
  • 首席研究员：Lin Shen, MD、Peking University Cancer Hospital, Beijing, Beijing 100142, China
  • 首席研究员：Markus Mohler, MD、Johannes Gutenberg University Clinic, Germany

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月20日

初级完成 (估计的)

2029年8月18日

研究完成 (估计的)

2030年8月18日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AK104-311

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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