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

• Status: Recruiting
• Trial end date: 2026-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

Criteria

Inclusion Criteria:

• Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically

• 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:

• Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vessels

• Vascular invasion involving inferior vena cava

• Central nervous system metastasis

• Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC

• History of organ and cell transplantation

• History of bleeding from esophageal and gastric varices

• History of hepatic encephalopathy

• hematologic examination: white blood cell count <3.0×10^9/L, platelets <50×10^9/L

• Prothrombin time prolongation ≥ 4s

• Severe organ (heart, lung, kidney) dysfunction

• History of malignancy other than HCC

• Active 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