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RECRUITING
NCT07023315
PHASE3

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

Sponsor: Akeso

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

760

Start Date

2025-08-14

Completion Date

2031-07

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

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

Locations (6)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Tianjin Provincial Tumor Hospital

Tianjin, Tianjin Municipality, China