60
Participants
Start Date
June 1, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2027
PD-1/CTLA-4 Dual Functional Antibody
"PD-1/CTLA-4 Dual Functional Antibody (iparomlimab and tuvonralimab injection):~5 mg/kg intravenous infusion every 3 weeks (day 1 of each 21-day cycle) for up to 6 cycles, with potential for maintenance therapy continuation. Used in combination with GP regimen in experimental arm only. This is a novel dual-functional antibody targeting both PD-1 and CTLA-4 pathways simultaneously."
Gemcitabine, Cisplatin
Gemcitabine 1000 mg/m² d1,8+Cisplatin 25mg/m² d1,8
Anlotinib
10mg po d1-14 q3w
Oxaliplatin + 5-Fluorouracil/Leucovorin
XELOX (oxaliplatin 130mg/m² d1+capecitabine 1000mg/m² d1-14 q3w) or FOLFOX6 (Oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² intravenous bolus followed by fluorouracil 2400 mg/m² 46 hours, q2w)
RECRUITING
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
First Affiliated Hospital of Zhejiang University
OTHER