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

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

• HCC confirmed by histopathology and/or cytology, or diagnosed clinically

• Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)

• Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included

• At least one measurable intrahepatic target lesion

• Child-Pugh class A/B

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy of at least 3 months

Exclusion Criteria:

• Extrahepatic metastasis

• Tumor thrombus involving main portal vein or both the first left and right branch of portal vein

• Vena cava invasion

• Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC

• History of organ and cell transplantation

• History of bleeding from esophagogastric varices

• History of hepatic encephalopathy

• Hematologic examination: platelets <50×10^9/L

• Prothrombin time prolongation ≥ 4s

• Severe organ (heart, lung, kidney) dysfunction

• History of malignancy other than HCC