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NOT YET RECRUITING
NCT07772557
PHASE2

Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This study evaluates the clinical efficacy and safety benefits of immunotherapy in a selected patient population by comparing serplulimab combined with short-course SOX regimen versus SOX regimen alone as adjuvant therapy for patients with stage pII-III gastric or gastroesophageal junction (G/EGJ) adenocarcinoma who are PD-L1 CPS ≥5, EBV-positive, or dMMR/MSI-H.

Official title: Efficacy and Safety of Serplulimab Combined With Short-Course SOX Regimen Versus SOX Regimen Alone as Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-09-01

Completion Date

2032-01-20

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

DRUG

Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg pe

SOX

DRUG

Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i

Serplulimab+SOX