MedTrace Logo

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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-07-14

No results posted yet for this 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.

Conditions

  • Gastric / Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Cadonilimab

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

DRUG

CAPOX regimen

A combination treatment contains oxaliplatin and capecitabine

DRUG

Nivolumab

Anti-PD-1 monoclonal antibody

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Jiafu Ji, MD · Peking University Cancer Hospital, Beijing, Beijing 100142, China

  • Lin Shen, MD · Peking University Cancer Hospital, Beijing, Beijing 100142, China

  • Markus Mohler, MD · Johannes Gutenberg University Clinic, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2029-08-18
Completion
2030-08-18
FDA Drug
Yes

Countries

  • United States
  • China
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700979 on ClinicalTrials.gov