RecruitingNot ApplicableNCT07408804

Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma


Sponsor

Bangladesh Medical University

Enrollment

40 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this interventional study is to compare treatment response between transarterial chemoembolization (TACE) combined with lenvatinib and lenvatinib monotherapy in patients with unresectable hepatocellular carcinoma. The study aims to determine whether the addition of TACE to lenvatinib results in improved tumor response compared with lenvatinib alone in a real-world clinical setting.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for liver cancer (hepatocellular carcinoma) that cannot be surgically removed: combining TACE (a procedure that delivers chemotherapy directly to the liver tumor while cutting off its blood supply) with lenvatinib (an oral targeted therapy drug) versus lenvatinib alone. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed to have hepatocellular carcinoma (HCC) by CT/MRI or biopsy - Your liver cancer is early to intermediate-advanced stage (BCLC A, B subgroup B, or C) with no prior treatment - You have at least one measurable tumor - Your daily functioning is reasonable (ECOG 0-2) **You may NOT be eligible if...** - Your liver cancer has spread extensively with more than 10 tumors or more than 50% liver involvement - You have a blood clot in the main portal vein (the major vessel supplying the liver) - Your liver function is severely impaired (Child-Pugh score 10 or above / ALBI grade 3) - You have uncontrolled high blood pressure, a recent heart attack, or blood clotting disorders - You have a known allergy or intolerance to lenvatinib 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

PROCEDURETACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)

Transarterial Chemoembolization will be done in the radiology department by an interventional radiologist. Lenvatinib will be started after 7 days following TACE according to body weight (8mg/day in patients with a body weight \<60 kg and 12mg/day in patients with a body weight of 60 kg or more)

DRUGLenvatinib

Lenvatinib will be started according to body weight ((8mg/day in patients with a body weight \<60 kg and 12mg/day in patients with a body weight of 60 kg or more)


Locations(1)

Department of Hepatology, Bangladesh Medical University

Dhaka, Bangladesh

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NCT07408804


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