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

NCT07432568 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2032-06-09
Completion
2032-08-09

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432568 on ClinicalTrials.gov