RecruitingPhase 2NCT06192797

Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

A Phase 2, Open-label, Single Arm Study of Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma


Sponsor

Tongji Hospital

Enrollment

36 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic artery infusion chemotherapy combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — HAIC (a direct liver infusion of chemotherapy), lenvatinib (a targeted oral drug), and pucotenlimab (an immunotherapy) — to try to shrink inoperable bile duct cancer inside the liver enough that surgery becomes possible. **You may be eligible if...** - You are 18 or older with confirmed cancer of the bile ducts inside the liver (intrahepatic cholangiocarcinoma) - Your cancer cannot be surgically removed based on specialist assessment - You have not received any prior systemic treatment for this cancer - Your general health (ECOG 0–1) and liver and kidney function meet study requirements - You have at least one measurable tumor **You may NOT be eligible if...** - You have previously received chemotherapy or immunotherapy for this cancer - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHAIC

administration of gemcitabine and oxaliplatin via the tumor feeding arteries every 3 weeks.

DRUGLenvatinib plus pucotenlimab

lenvatinib (8mg, qd) plus pucotenlimab (200mg, q3w)


Locations(1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06192797


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