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Clinical Trials in China / NCT07700979
Starting soon Phase 3

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

NCT07700979 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 3
Started
2026-08-20
Last updated
2026-07-14

Condition(s) studied

Gastric / Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

CadonilimabCAPOX regimenNivolumabPlacebo

Cadonilimab: Anti-PD-1/ CTLA-4 tetrameric bispecific antibody

CAPOX regimen: A combination treatment contains oxaliplatin and capecitabine

Nivolumab: Anti-PD-1 monoclonal antibody

Placebo: Placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona
UCLA Health Los Angeles California
Rocky Mountain Cancer Centers Denver Colorado
Yale School of Medicine New Haven Connecticut
Dana Farber Cancer Institute Boston Massachusetts
Henry Ford Health Detroit Michigan
Mount Sinai New York New York
Memorial Sloan Kettering Cancer Center New York New York
Oregon Health and Science University Portland Oregon
Sarah Cannon Research Institute (SCRI) - Oncology Partners Nashville Tennessee
Baylor Scott & White Health Dallas Texas
MD Anderson Cancer Center Houston Texas
University of Wisconsin Carbone Cancer Center Madison Wisconsin
Beijing Friendship Hospital, Capital Medical University Beijing China
Peking University Cancer Hospital, Gastrointestinal Cancer Center I Beijing China
Peking University Cancer Hospital, Gastrointestinal Oncology Beijing China
Guangdong Provincial People's Hospital Guangzhou China
Zhongshan Hospital Fudan University Shanghai China
Universitaetsklinikum Essen Essen North Rhine-Westphalia
University Cancer Center Frankfurt Frankfurt Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Germany
Univerity Marburg Marburg Germany
Pratia MCM Kraków Krakow Poland
Pratia Poznań Poznan Poland
Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie Warsaw Poland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07700979 on ClinicalTrials.gov ↗ ← All trials in China