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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • QLS31905
  • Sintilimab
  • Oxaliplatin
  • Capecitabine

Treatment groups

560 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators