Lenvatinib Plus Sintilimab vs. Lenvatinib for Advanced HCC Treated With TACE

This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab (Len-Sin) compared with lenvatinib (Len) alone as maintenance therapy for patients with advanced hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE).

Inclusion Criteria:Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinicallyPatients 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:Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vesselsVascular invasion involving inferior vena cavaCentral nervous system metastasisPatients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCCHistory of organ and cell transplantationHistory of bleeding from esophageal and gastric varicesHistory of hepatic encephalopathyhematologic examination: white blood cell count <3.0×10^9/L, platelets <50×10^9/LProthrombin time prolongation ≥ 4sSevere organ (heart, lung, kidney) dysfunctionHistory of malignancy other than HCCActive hepatitis B or C infection; hepatitis B virus (HBV) DNA > 1000 copies/ml; hepatitis C virus (HCV) RNA > 1000 copies/ml. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled