NCT07263386

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	For patients with body weight \< 60 kg, the dose is 3 mg/kg, administered via intravenous infusion (i.v.gtt.) on Day 1; for patients with body weight ≥ 60 kg, a fixed dose of 200 mg is administered via intravenous infusion (i.v.gtt.) on Day 1. The treatment is repeated every 21 days.
DRUG	SOX Chemotherapy	S-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.

Timeline

• Start date: 2025-10-23
• Primary completion: 2028-10-01
• Completion: 2030-10-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: China