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Trial Title:
Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma
NCT ID:
NCT06530784
Condition:
Carcinoma, Hepatocellular
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Antibodies
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Cryoablation combined with PD-1 antibody and bevacizumab
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cryoablation
Description:
After the completion of screening, the subjects received cryoablation treatment
Arm group label:
treatment group
Intervention type:
Drug
Intervention name:
PD-1 antibody and bevacizumab
Description:
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.
Arm group label:
treatment group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Mengjie Yang
Phone:
+86 21 31587871
Email:
yang.mengjie@zs-hospital.sh.cn
Start date:
July 31, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06530784
