NCT07023315

A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma

A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.

Detailed description

This trial is a Phase 3 study. All patients are resectable gastric or gastroesophageal junction adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.

Conditions

• Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab	Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
DRUG	SOX chemotherapy	A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-08-14
• Primary completion: 2029-07-01
• Completion: 2031-07-01
• First posted: 2025-06-16
• Last updated: 2026-02-11

Locations

6 sites across 1 country: China