Phase II Study Comparing Sintilimab Plus SOX Versus SOX Alone as Additional Treatment After Surgery for PD-L1-Positive Stage N3 Gastric Cancer

What this Trial Is About

Researchers are evaluating treatments for patients with PD-L1-positive, Stage N3 gastric cancer who have undergone surgery. This Phase II study aims to find out if adding the PD-1 inhibitor sintilimab to the standard SOX chemotherapy regimen after surgery can improve the time patients remain free from cancer Disease-Free Survival. The trial compares two groups to see if this combination therapy is more effective than chemotherapy alone. Participants are randomly assigned to one of two groups. One group receives 6 to 8 cycles of sintilimab combined with the SOX chemotherapy regimen, followed by continued sintilimab as maintenance treatment for up to one year. The other group receives 6 to 8 cycles of only the SOX chemotherapy regimen. The SOX regimen includes oral S-1 twice daily for 14 days and an intravenous infusion of oxaliplatin on Day 1, repeated every 21 days. Sintilimab is given intravenously every 21 days, with dosing based on body weight. Throughout the study, participants will be monitored regularly with assessments to measure outcomes such as Disease-Free Survival over 3 years, Overall Survival over 5 years, and the occurrence of side effects including serious adverse events. Safety and health will be closely observed during treatment and follow-up. The study is expected to last until October 2030, involving adult patients aged 18 to 75 years who meet specific medical and laboratory requirements.

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