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

Hepatocellular Carcinoma Non-resectable Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

This is a single-center, prospective and randomized controlled trial to evaluate the efficacy and safety of Len-I versus Len alone for patients with TACE-refractory HCC.

187 patients with TACE-refractory HCC will be enrolled in this study. The patients will receive either Len-I or Len alone using an 2:1 randomization scheme.

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the Len-I arm, 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.

The primary end point of this study is overall survival (OS). The secondary endpoints are progression-free survival (PFS), time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

• NCT number: NCT05608213
• Study type: Interventional
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Mingyue Cai, MD
• Phone: +86-20-34156205
• Email: cai020@yeah.net
• Status: Recruiting
• Phase: Phase 3
• Start date: November 2, 2022
• Completion date: December 1, 2026