RecruitingPhase 3NCT05608213

Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC

Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

187 participants

Start Date

Nov 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares lenvatinib (a targeted drug) combined with radioactive seed implants (a radiation technique called I-125 brachytherapy) versus lenvatinib alone for people with liver cancer (HCC) that has stopped responding to TACE (a standard liver-targeted procedure). **You may be eligible if...** - You have liver cancer confirmed by biopsy or clinical criteria - Your liver cancer no longer responds to TACE (called TACE-refractory) based on Japan Society of Hepatology criteria - You have at least one measurable liver tumor - Your liver function is acceptable (Child-Pugh class A or B) - Your performance status is ECOG 0 or 1 and life expectancy is at least 3 months **You may NOT be eligible if...** - Your cancer has spread outside the liver (extrahepatic metastasis) - You have tumor blocking the main portal vein on both sides - You have other serious health conditions (check full eligibility with your doctor) 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

PROCEDURELenvatinib Plus I-125 Seed Brachytherapy

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients. Iodion-125 seeds will be implanted into the the target lesions (viable intrahepatic tumor and/or vascular tumor thrombus) under CT guidance according to the pre-operative planning within 7 days after lenvatinib administration. Iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

DRUGLenvatinib

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients.


Locations(1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT05608213


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