Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Iparomlimab and Tuvonralimab:5 mg/kg Q3W lenvatinib:8 mg/day orally SOX:oxaliplatin (130 mg/m² Q3W intravenous infusion), and S-1 (40 mg/m² BID orally on days 1-14)
Pathological complete response (pCR) rate
Time frame: Up to approximately 2 years
Major pathological response (MPR) rate
Time frame: Up to approximately 2 years
R0 resection rate
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Event-free survival (EFS)
Time frame: Up to approximately 2 years
12-month, 24-month, and 36-month event-free survival rates Disease-free survival (DFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 5 years
12-month, 24-month, and 36-month overall survival rates
Time frame: Up to approximately 3 years
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