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

NCT07716449 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2026-07-21

No results posted yet for this study

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 unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Conditions

  • Gastric or Gastroesophageal Junction Adenocarcinoma

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).

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-09-30
Completion
2029-08-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716449 on ClinicalTrials.gov