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.
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,
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,
Parallel
TACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib)
Procedure/SurgeryTransarterial 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
DrugLenvatinib 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)
To compare the objective response rate between a combination of Transarterial Chemoembolization and Lenvatinib therapy versus Lenvatinib monotherapy in patients with unresectable Hepatocellular carcinoma
To compare tumor size on dynamic CT scan or MRI according to mRECIST criteria between the TACE plus Lenvatinib group and the Lenvatinib group after 3 months of treatment.
To compare new intrahepatic lesions and/ or extrahepatic metastatic lesions ( portal vein, intra-abdominal lymph node, lungs ) with dynamic CT scan or MRI according to mRECIST criteria between the TACE plus Lenvatinib group and the Lenvatinib group
To compare the Albumin-Bilirubin score (ALBI score) of patients between the TACE plus lenvatinib group and the Lenvatinib group
Albumin-bilirubin score scale range : -2.6 to +0.20 Lower (more negative) scores indicate better liver function, higher scores (more towards positive) worse liver fuction.
To compare the alpha-fetoprotein level of patients between the TACE plus lenvatinib group and the Lenvatinib group
Serum alpha feto-protein (AFP) level is measured in ng/ml. Lower AFP levels indicate better treatment response.
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