The EDC is live today — see what ships now
All studies
NCT07700979From ClinicalTrials.govRecruiting

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
Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolum | Trialion