Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

Prior treatment

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

Other illness

• History of organ and cell transplantation
• History of esophageal or gastric variceal bleeding
• History of hepatic encephalopathy
• History of other malignancies
• Human immunodeficiency virus infection

Other

• Extrahepatic metastasis
• Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
• Vena cava invasion

• Pathologically confirmed or clinically diagnosed HCC
• 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
• Tumor extent \<70% liver occupation
• Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
• Adequate organ and hematologic function with platelet count ≥50×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
• Life expectancy of at least 3 months