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RECRUITING
NCT05608213
PHASE3

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

Sponsor: Second Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

187

Start Date

2022-11-02

Completion Date

2026-12-01

Last Updated

2022-11-08

Healthy Volunteers

No

Interventions

PROCEDURE

Lenvatinib 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.

DRUG

Lenvatinib

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