The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib for patients with unresectable liver metastasis, who had progressed after, or were refractory to first- or later-line therapy.
Written informed consent obtained.
Age ≥ 18 years at time of study entry.
Participants must have unresectable liver metastasis from solid tumors.
Participants must have progressed after, or were refractory to first- or later-line therapy in the liver metastatic setting.
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 than 4 weeks prior to study treatment start.
Single group
Sintilimab
DrugSintilimab plus lenvatinib will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks.
Lenvatinib
DrugSintilimab plus lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) was given orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Cryoablation
DrugCryoablation treatment starts at day 0. Cryoablation 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 according to RECIST 1.1
DoR
Duration of Response
PFS
Progression Free Survival
OS
Overall survival
DCR
disease control rate
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