NCT07432568

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

A Prospective Study on the Efficacy and Safety of Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Lenvatinib and a PD-1 Inhibitor as First-Line Therapy for Advanced Intrahepatic Cholangiocarcinoma (ICC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study investigates a novel therapeutic strategy for unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC). Despite being the second most common primary liver malignancy, advanced ICC has a poor prognosis with limited effective first-line treatment options. The rationale for this combination regimen is based on the potential synergy between localized and systemic therapies. Hepatic arterial infusion chemotherapy delivers high concentrations of chemotherapy directly to the liver tumors, potentially improving local control while reducing systemic toxicity. The combination of Lenvatinib, a multi-targeted tyrosine kinase inhibitor, and a PD-1 inhibitor is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immunity. This study will explore whether combining these modalities (HAIC + targeted therapy + immunotherapy) can yield superior efficacy compared to historical data of standard chemotherapy. The liposomal formulation of irinotecan is utilized for its improved pharmacokinetic profile and targeted delivery, which may enhance efficacy and tolerability. Key assessments include tumor evaluation based on RECIST 1.1 criteria and safety monitoring per NCI CTCAE v5.0.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
OTHER	Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin	Liposomal Irinotecan (70 mg/m²) infused over 90 minutes, followed by Leucovorin (400 mg/m²) infused over 2 hours, and then 5-Fluorouracil (2400 mg/m²) infused over 24 hours via hepatic arterial infusion on Day 1 of each 21-day cycle. The number of treatment cycles (2 to 6) is determined by the investigator based on tumor response and tolerability after the initial 2 cycles.
DRUG	Lenvatinib	Lenvatinib is administered orally at a dose of 8 mg once daily, continuously throughout each 21-day cycle.
DRUG	PD-1 Inhibitor	A PD-1 inhibitor (specific agent chosen at the investigator's discretion) is administered via intravenous infusion on Day 1 of each 21-day cycle, approximately 24 hours prior to the initiation of HAIC.

Timeline

• Start date: 2026-03-09
• Primary completion: 2032-06-09
• Completion: 2032-08-09
• First posted: 2026-02-25
• Last updated: 2026-02-25