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

ConditionIntrahepatic Cholangiocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years.

Histologically or cytologically confirmed unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC).

Liver function: Child-Pugh class A (score 5-6) or good class B (score ≤7).

At least one measurable lesion as defined by RECIST 1.1 criteria.

Disqualifiers

History of other malignancies within the past 5 years (except cured carcinoma in situ or basal cell skin cancer).

Significant clinical bleeding symptoms or tendency within 3 months prior to treatment (e.g., >30 mL bleeding, hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks). Venous/thrombotic events within the past 6 months (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism). Requirement for long-term anticoagulation (e.g., warfarin, heparin) or antiplatelet therapy (Aspirin ≥300 mg/day or Clopidogrel ≥75 mg/day).

Extensive distant metastasis (e.g., peritoneal metastasis, multiple bone/brain metastases).

Use of strong CYP3A4 inducers within 3 weeks prior to first dose, or use of strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 3 weeks prior to first dose.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hepatic Arterial Infusion Chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, Leucovorin

    Other intervention

    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.

  • Lenvatinib

    Drug

    Lenvatinib is administered orally at a dose of 8 mg once daily, continuously throughout each 21-day cycle.

  • PD-1 Inhibitor

    Drug

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Combination Therapy GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Time frame
Every 2 cycles (each cycle is 21 days ) during the treatment period

Secondary outcomes

1

Progression-Free Survival (PFS)

Time frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
2

Overall Survival (OS)

Time frame
From date of first dose until the date of death from any cause, assessed up to 60 months
3

Disease Control Rate (DCR)

Time frame
From date of first dose until the date of first documented progression or the end of treatment, whichever came first, assessed up to 24 months
4

Conversion Resection Rate

Time frame
From date of first dose until the date of radical surgery, assessed up to 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: