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RECRUITING
NCT07716449
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

QLS31905

QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

DRUG

Sintilimab

Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

DRUG

Oxaliplatin

Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

DRUG

Capecitabine

Capecitabine will be administered orally twice daily (bid).

Locations (1)

Beijing Cancer Hospital

Beijing, China