The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus lenvatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma.
Written informed consent obtained.
Age ≥ 18 years at time of study entry.
Participants must have unresectable or metastatic histologically or cytologically confirmed hepatocellular carcinoma
Participants must have failed 1 line of systemic regimens for advanced hepatocellular carcinoma due to disease progression or toxicity.
History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
Prior treatment with cryoablation.
RFA and resection administered less then 4 weeks prior to study treatment start.
Single group
Tislelizumab
DrugTislelizumab will be initiated on day 14 after cryoablation. Tislelizumab will be administered at 200 mg i.v. every 3 weeks
lenvatinib
DrugLenvatinib will be initiated on day 14 after cryoablation. Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
US/CT-guided Percutaneous Cryoablation
Combination productCryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone
Objective Response Rate (ORR)
ORR according to RECIST 1.1
DoR
Duration of Response
PFS
Progression Free Survival
OS
Overall survival
DCR
disease control rate
Click on the lead sponsor to view all of their trials.
