Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma
Bangladesh Medical University
40 participants
Apr 8, 2025
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
Inclusion Criteria4
- Age 18-75 years,
- Hepatocellular carcinoma, confirmed by dynamic CT scan / MRI or histopathology, consistent with early (stage A), Intermediate (Stage B), subgroup B, and Advanced (stage C) according to BCLC criteria 2022, without a history of any previous treatment,
- At least one measurable lesion based on mRECIST criteria,
- ECOG performance status 0-2,
Exclusion Criteria6
- Diffuse bi-lobar or multi nodular HCC (more than 10 nodules) with more than equal 50% liver involvement,
- Hepatocellular carcinoma with main trunk portal vein thrombosis,
- Child Turcotte Pugh Score 10 ( C) or more,
- ALBI grade 3,
- Hepatocellular carcinoma with uncontrolled hypertension, recent myocardial infarction, or other thromboembolic event,
- Known allergy or intolerance to lenvatinib .
Interventions
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)
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)
View Full Details on ClinicalTrials.gov
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NCT07408804