The objective of this study is to evaluate the efficacy and safety of Lenvatinib plus Sintilimab in patients with advanced liver cancer progressed after treatment with immune checkpoint inhibitors.
Written informed consent obtained.
Age ≥ 18 years at time of study entry.
Participants must have unresectable or metastatic histologically or cytologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma
Participants must have disease progression with an anti-PD-1 or anti-PD-L1 based regimen.
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 Lenvatinib or other targeted therapy.
RFA and resection administered less then 4 weeks prior to study treatment start.
Single group
Sintilimab
DrugSintilimab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Lenvatinib
DrugLenvatinib 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.
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
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