Clinical Trial

A Study of Liposomal Irinotecan Plus 5-FU/LV HAIC With Lenvatinib and a PD-1 Inhibitor in Advanced ICC

Not Yet Recruiting Phase 2
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Summary
This is a prospective, single-center, single-arm clinical study. It aims to evaluate the efficacy and safety of a new combination therapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC) who cannot be treated with surgery. The combined therapy includes hepatic arterial infusion chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin, along with the oral targeted drug Lenvatinib and an intravenous PD-1 inhibitor (an immunotherapy). A total of 30 participants will be enrolled. The main goal of the study is to measure the Objective Response Rate (ORR), which is the percentage of patients whose cancer shrinks or disappears after treatment.
Trial Details
NCT Number NCT07432568
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Intrahepatic Cholangiocarcinoma
Enrollment 30 participants
Start Date 2026-03-09
Primary Completion 2032-06-09 (estimated)
Study Completion 2032-08-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-25