Carcinoma, Hepatocellular
Conditions
Brief summary
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.
Interventions
PROCEDURECryoablation
After the completion of screening, the subjects received cryoablation treatment
DRUGPD-1 antibody and bevacizumab
Three 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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cryoablation combined with PD-1 antibody and bevacizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 80 years old, and expected survival is longer than 3 months 2. Clinically or pathologically diagnosed as primary hepatocellular carcinoma 3. Disease progression assessed according to mRECIST criteria after PD-1/L1 antibody treatment 4. Child-Pugh score of liver function A/B (\< 7) 5. At least one lesion is suitable for mRECIST assessment 6. Strength score (ECOG): 0-1 7. The patient and/or family members agree to join the clinical trial and sign the informed consent form
Exclusion criteria
1. Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon 2. Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation 3. 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 4. Pregnant patients 5. Combined with other malignant tumors, or have a history of other malignant tumors within 3 years 6. Active autoimmune disease, confirmed immunodeficiency, history of systemic steroid medication 7. Severe renal dysfunction: creatinine (Cr) \> 2 mg/dL or creatinine clearance (CCr) \<30 mL/min, severe heart, lung, brain and other important organ diseases 8. History of gastrointestinal bleeding within 3 months 9. Unable to cooperate with ablation surgery 10. Severe gastroesophageal varices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to 2 years | mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progress | Up to 2 years | mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit. |
| Objective Response Rate | Up to 2 years | mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit. |
| Overall survival | Up to 2 years | According to medical documents or descriptions of the patient's family |
| Adverse events | Up to 2 years | CTCAE v5.0 is used to assess adverse events. |
Countries
China
Contacts
Primary ContactLingxiao Liu
Outcome results
None listed