About this trial
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma after progression on first line systemic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained.
Age ≥ 18 years at time of study entry.
Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma
Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.
Disqualifiers
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.
Radiofrequency ablation and resection administered less then 4 weeks prior to study treatment start.
Radiotherapy administered less then 4 weeks prior to study treatment start.
Trial design
Single group
Treatments tested in this trial
Camrelizumab
Druga PD-1 immune check inhibitor
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
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate
Objective Response Rate according to modified RECIST for Hepatocellular Carcinoma
Secondary outcomes
Duration of Response
Progression Free Survival
Overall survival
disease control rate
Sponsors and contacts
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