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.
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;
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;
Parallel
QLS31905
DrugQLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Sintilimab
DrugSintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Oxaliplatin
DrugOxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Capecitabine
DrugCapecitabine will be administered orally twice daily (bid).
Progression free survival (PFS)
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease by Blinded Independent Central Review (BICR) evaluation or death due to any cause (whichever occurs first).
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This trial is not recruiting at the moment. You can still explore other options:
