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

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).

Inclusion Criteria:HCC confirmed by histopathology and/or cytology, or diagnosed clinicallyDiagnosis 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 includedAt least one measurable intrahepatic target lesionChild-Pugh class A/BEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy of at least 3 monthsExclusion Criteria:Extrahepatic metastasisTumor thrombus involving main portal vein or both the first left and right branch of portal veinVena cava invasionPatients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCCHistory of organ and cell transplantationHistory of bleeding from esophagogastric varicesHistory of hepatic encephalopathyHematologic examination: platelets <50×10^9/LProthrombin time prolongation ≥ 4sSevere organ (heart, lung, kidney) dysfunctionHistory of malignancy other than HCC