Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer

Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib/II trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC. It conducts dose exploration to confirm the optimal dosage and evaluates clinical outcomes, aiming to establish a better comprehensive treatment strategy.

NCT Number	NCT07636798
Lead Sponsor	West China Hospital
Conditions	Biliary Tract Cancer
Enrollment	20 participants
Start Date	2026-06
Primary Completion	2029-03 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-09