Clinical trialNCT07700979Not, yet, recruitingPhase 3Interventional

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

SponsorAkesoEnrollment900Gastric / Gastroesophageal Junction Adenocarcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jiafu Ji, MD
Peking University Cancer Hospital, Beijing, Beijing 100142, China
Principal Investigator
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Lin Shen, MD
Peking University Cancer Hospital, Beijing, Beijing 100142, China
Principal Investigator
clinicaltrials.gov ↗
Markus Mohler, MD
Johannes Gutenberg University Clinic, Germany
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

25 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

China

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

Germany

Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
University Cancer Center Frankfurt
Frankfurt, Germany
Universitätsmedizin Der Johannes Gutenberg-Universität
Mainz, Germany
Univerity Marburg
Marburg, Germany

Poland

Pratia Mcm Kraków
Krakow, Poland
Pratia Poznań
Poznan, Poland
Narodowy Instytut Onkologii-Im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - W Warszawie
Warsaw, Poland

United States

Mayo Clinic
Phoenix, Arizona, United States
Ucla Health
Los Angeles, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Mount Sinai
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Sarah Cannon Research Institute (scri) - Oncology Partners
Nashville, Tennessee, United States
Baylor Scott & White Health
Dallas, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CAPOX regimenCadonilimabNivolumab →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Aug 2026
Primary completion: 18 Aug 2029
Completion: 18 Aug 2030
Last update posted: 14 Jul 2026
Registered enrollment: 900
Registry id: NCT07700979

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.