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
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
- Gastric / Gastroesophageal Junction Adenocarcinoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Akeso
- Enrolment target
- 900
- Started
- 24 September 2026
- Main results due
- 18 August 2029
- Study sites
- 25
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(25)
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
Henry Ford Health
Detroit, Michigan, United States
Not yet recruiting
Mount Sinai
New York, New York, United States
Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Not yet recruiting
Oregon Health and Science University
Portland, Oregon, United States
Not yet recruiting
Sarah Cannon Research Institute (SCRI) - Oncology Partners
Nashville, Tennessee, United States
Not yet recruiting
Baylor Scott & White Health
Dallas, Texas, United States
Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Not yet recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Not yet recruiting
Peking University Cancer Hospital, Gastrointestinal Cancer Center I
Beijing, China
Recruiting
Peking University Cancer Hospital, Gastrointestinal Oncology
Beijing, China
Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, China
Not yet recruiting
Zhongshan Hospital Fudan University
Shanghai, China
Not yet recruiting
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Not yet recruiting
University Cancer Center Frankfurt
Frankfurt, Germany
Not yet recruiting
Universitätsmedizin der Johannes Gutenberg-Universität
Mainz, Germany
Not yet recruiting
Univerity Marburg
Marburg, Germany
Not yet recruiting
Pratia MCM Kraków
Krakow, Poland
Not yet recruiting
Pratia Poznań
Poznan, Poland
Not yet recruiting
Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie
Warsaw, Poland
Not yet recruiting
Showing 25 of 25 sites. 1 of the 25 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07700979. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me