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QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
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 , Her-2 Negtive unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Official title: A Randomized, Open-label, Multicenter Phase III Clinical Study of QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic CLDN18.2-positive, PD-L1 CPS < 5 ,Her-2 Negtive Gastric or Gastroesophageal Junction Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
560
Start Date
2026-09-24
Completion Date
2029-08
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
QLS31905
QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Sintilimab
Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Oxaliplatin
Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Capecitabine
Capecitabine will be administered orally twice daily (bid).
Locations (1)
Beijing Cancer Hospital
Beijing, China