RecruitingPhase 2NCT06187961

Combined HAIC, Lenvatinib and Cadonilimab As Conversion Therapy for Unresectable Hepatocellular Carcinoma

A Phase 2, Open-label, Single Arm Study of Combined HAIC, Lenvatinib and Cadonilimab As Conversion Therapy for Unresectable Hepatocellular Carcinoma


Sponsor

Tongji Hospital

Enrollment

36 participants

Start Date

Dec 7, 2023

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 arterial infusion chemotherapy combined with lenvatinib and cadonilimab as conversion therapy for unresectable hepatocellular carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a triple combination approach — hepatic arterial infusion chemotherapy (HAIC, delivered directly to liver tumors), lenvatinib (an oral targeted therapy), and cadonilimab (an immunotherapy) — to shrink unresectable liver cancer (hepatocellular carcinoma) enough to allow surgery. **You may be eligible if...** - You are 18 or older and have been diagnosed with hepatocellular carcinoma (HCC), confirmed by biopsy or standard imaging criteria - Your cancer currently cannot be removed by surgery - You are in good general health (ECOG performance status 0 or 1) - Your liver function is adequate **You may NOT be eligible if...** - Your cancer has spread to distant organs beyond the liver (extensive metastases) - You have serious heart, kidney, or clotting problems - You have uncontrolled 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 oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.

DRUGLenvatinib plus cadonilimab

lenvatinib (8mg, qd) plus cadonilimab (10mg/kg, q3w)


Locations(1)

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

Wuhan, Hubei, China

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NCT06187961


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