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A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
Sponsor: Akeso
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
Cadonilimab
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
SOX chemotherapy
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
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