RecruitingPhase 3NCT07023315

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


Sponsor

Akeso

Enrollment

760 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing whether adding an immunotherapy drug (cadonilimab) to standard chemotherapy (SOX regimen) before and after surgery improves outcomes for people with resectable stomach or gastroesophageal junction cancer. **You may be eligible if...** - You have been diagnosed with stomach cancer or cancer where the stomach meets the esophagus, confirmed by biopsy - Your cancer is considered surgically removable (resectable, stage T3–T4b) - You are in good health and able to carry out daily activities (ECOG 0–1) - Your life expectancy is at least 6 months - You have not received any prior cancer treatment for this diagnosis - Your organ function (blood, liver, kidneys) is adequate **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have a different type of cancer (not adenocarcinoma) - You are taking immunosuppressive medications - You have an active autoimmune disease - You have an active or serious infection - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab

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

DRUGSOX chemotherapy

A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07023315


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