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Clinical trial

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 Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07716449 is registered in ClinicalTrials.gov with Qilu Pharmaceutical Co., Ltd. as lead sponsor.

NCT NCT07716449
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Registry record

As filed in ClinicalTrials.gov.

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 Gastric or Gastroesophageal Junction Adenocarcinoma
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 3
Overall status
Not yet recruiting
Start date
August 31, 2026
Completion date
August 31, 2029
Enrollment
560 (estimated)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

gastric or gastroesophageal junction adenocarcinoma