Cadonilimab with chemotherapy vs chemotherapy with/without nivolumab as first-line treatment for HER2-negative advanced gastric/GEJ cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, phase 3 trial conducted across multiple regions. Participants with newly diagnosed, unresectable or metastatic HER2-negative gastric/GEJ adenocarcinoma receive cadonilimab plus chemotherapy or chemotherapy alone, with or without nivolumab, to compare overall survival. Eligible patients have ECOG 0-1, measurable disease, and adequate organ function, and have not received prior systemic therapy for advanced disease. The trial uses the CAPOX chemotherapy backbone and includes a placebo control for the nivolumab comparison. Primary analysis focuses on overall survival in the intent-to-treat population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Cancer Hospital, Gastrointestinal Cancer Center I
  Beijing, China Recruiting
• Mayo Clinic
  Phoenix, Arizona, United States Not yet recruiting
• UCLA Health
  Los Angeles, California, United States Not yet recruiting
• Rocky Mountain Cancer Centers
  Denver, Colorado, United States Not yet recruiting
• Yale School of Medicine
  New Haven, Connecticut, United States Not yet recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Jiafu Ji, MD — Peking University Cancer Hospital, Beijing, Beijing 100142, China
• Study coordinator: Zhifang Yao, MD
• Email: clinicaltrials@akesobio.com
• Phone: 86-0760-89873999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.