About this trial
To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years old, and expected survival is longer than 3 months
Clinically or pathologically diagnosed as primary hepatocellular carcinoma
Disease progression assessed according to mRECIST criteria after PD-1/L1 antibody treatment
Child-Pugh score of liver function A/B (< 7)
Disqualifiers
Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon
Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation
Patients with chronic viral hepatitis (hepatitis B, hepatitis C) have a viral load greater than 10^4 before receiving treatment or do not continue to take antiviral drugs regularly
Pregnant patients
Trial design
Single group
Treatments tested in this trial
Cryoablation
Procedure/SurgeryAfter the completion of screening, the subjects received cryoablation treatment
PD-1 antibody and bevacizumab
DrugThree days after cryoablation, the patients receive intravenous infusion of Tislelizumab (200mg, with 100mL of normal saline) and Bevacizumab (dose 15mg/kg, with 100mL of normal saline) .The patients will receive Tislelizumab (200 mg, with 100 mL of normal saline) and Bevacizumab (15 mg/kg, with 100 mL of normal saline) once every 3 weeks until disease progression.
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
Secondary outcomes
Time to progress
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
Objective Response Rate
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
Overall survival
According to medical documents or descriptions of the patient's family
Adverse events
CTCAE v5.0 is used to assess adverse events.
Sponsors and contacts
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