QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ

This study is a randomized, open, multicenter phase III clinical study designed to compare the efficacy and safety of QLS31905 injection combined with CAPOX versus sintilimab combined with CAPOX in the first-line treatment of CLDN18.2 positive, PD-L1 CPS \< 5 unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

NCT Number	NCT07716449
Lead Sponsor	Qilu Pharmaceutical Co., Ltd.
Conditions	Gastric or Gastroesophageal Junction Adenocarcinoma
Enrollment	560 participants
Start Date	2026-08
Primary Completion	2028-09 (estimated)
Study Completion	2029-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-21