Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Bile Duct CarcinomaGall Bladder CancerBiliary Tract CancerCholangiocarcinoma
Interventions
DRUG

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."

DRUG

Gemcitabine, Cisplatin

Gemcitabine 1000 mg/m² d1,8+Cisplatin 25mg/m² d1,8

DRUG

Anlotinib

10mg po d1-14 q3w

DRUG

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)

Trial Locations (1)

310003

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

First Affiliated Hospital of Zhejiang University

OTHER

NCT07025174 - Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer | Biotech Hunter | Biotech Hunter