Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC

Recruiting now · Phase 3

Conditions studied: Hepatocellular Carcinoma Non-resectable

In brief

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).

Key facts

Study ID

NCT05608200

Run by

Second Affiliated Hospital of Guangzhou Medical University

People needed

427

Starts

2022-11-02

Expected to finish

2026-10-31

Last updated by the study team

2023-05-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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