A single-arm, Phase II clinical study protocol of Apatolimab Tovolimab in combination with regorafenib and chemotherapy as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Iparomlimab and Tuvonralimab:5mg/kg,Intravenous infusion,Q3W regorafenib:80mg,oral administration once daily from Day 1 to Day 14 chemotherapy:XELOX or SOX
Objective response rate
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 5 years
The incidence and severity of adverse events (AE) during the study period (Safety)
The incidence and severity of adverse events (AE) during the study period
Time frame: Up to approximately 2 years
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