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RECRUITING Phase 3 ClinicalTrials.gov

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. • ClinicalTrials.gov ID: NCT07716449

Registry updated: 2026-10-19
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Description

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.

Interventions

  • QLS31905 (Drug)
    QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
  • Sintilimab (Drug)
    Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
  • Oxaliplatin (Drug)
    Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
  • Capecitabine (Drug)
    Capecitabine will be administered orally twice daily (bid).

Eligibility criteria

Inclusion Criteria: * Subjects voluntarily participate in the study and sign the informed consent form; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; * Expected survival time ≥ 12 weeks; * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma; * No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease; * Has measurable or non-measurable (but assessable) disease; * Patients with adequate cardiac, liver, renal function, etc. Exclusion Criteria: * Known history of allergy to any component of the study drug; * Other second primary malignant neoplasm within 5 years; * Significant cardiovascular and cerebrovascular disorders within 6 months before randomization; * Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation; * Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc; * Previous treatment targeting CLDN18.2; * Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.

Conditions

Gastric or Gastroesophageal Junction Adenocarcinoma

Locations

  • Beijing Cancer Hospital — Beijing, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record