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 (ARTEMIS-GC3)

NCT07263386 Phase 2 RECRUITING

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.

Details

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	RECRUITING
Enrolment	460
Start date	2025-10-23
Completion	2030-10

Conditions

• Gastric Adenocarcinoma

Interventions

• Sintilimab
• SOX Chemotherapy

Primary outcomes

• Disease-Free Survival (DFS) — 3 years
  Defined from the date of completion of curative-intent treatment (e.g., surgery, adjuvant chemotherapy) to the date of first documentation of disease recurrence (e.g., tumor relapse, metastasis) or death from any cause, whichever occurs first.

Countries

China