About this trial
This study evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. All enrolled participants receive induction treatment with sintilimab plus lenvatinib for 4 cycles. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for complete consolidation are randomized in a 1:1 ratio to receive either comprehensive local consolidative therapy followed by continued systemic therapy or continued systemic therapy alone. The primary outcome is overall survival.
Eligibility criteria
Qualifiers
Age 18 to 75 years
Hepatocellular carcinoma confirmed by imaging and/or histology according to institutional diagnostic standards
Advanced or unresectable disease with extrahepatic metastases meeting protocol-defined oligo-extrahepatic metastatic disease criteria: 1 to 5 extrahepatic metastatic lesions and no more than 2 involved extrahepatic organs
At least 1 measurable lesion according to RECIST version 1.1
Disqualifiers
More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs
Diffuse peritoneal seeding, leptomeningeal disease, or uncontrolled brain metastases
Main portal vein trunk invasion, extensive inferior vena cava or right atrial tumor thrombus, or disease considered unlikely to become fully consolidable after induction
Diffuse intrahepatic disease or liver tumor burden considered unlikely to be controllable with protocol-specified local treatment
Trial design
Treatments tested in this trial
- Sintilimab
- Lenvatinib
- Comprehensive Local Consolidative Therapy