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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.
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).
Time frame: Up to 44 months
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Capecitabine will be administered orally twice daily (bid).