A Phase II, Multicenter, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Sintilimab Plus SOX Versus SOX Alone as Adjuvant Therapy for PD-L1-Positive, Stage pN3 Gastric Cancer

This study intends to enroll gastric cancer patients who are PD-L1 positive and pathologically confirmed as Stage N3. Enrolled patients will be randomly assigned to receive either standard adjuvant SOX regimen or SOX regimen combined with sintilimab. The objective of the study is to determine whether adding a PD-1 inhibitor to postoperative chemotherapy can improve the Disease-Free Survival (DFS) rate in patients with Stage N3 gastric cancer.

NCT Number	NCT07263386
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University
Conditions	Gastric Adenocarcinoma
Enrollment	460 participants
Start Date	2025-10-23
Primary Completion	2028-10 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2025-12-04