Status:
NOT_YET_RECRUITING
Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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)
- At least one lesion is suitable for mRECIST assessment
- Strength score (ECOG): 0-1
- The patient and/or family members agree to join the clinical trial and sign the informed consent form
Exclusion
- 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
- Combined with other malignant tumors, or have a history of other malignant tumors within 3 years
- Active autoimmune disease, confirmed immunodeficiency, history of systemic steroid medication
- Severe renal dysfunction: creatinine (Cr) \> 2 mg/dL or creatinine clearance (CCr) \<30 mL/min, severe heart, lung, brain and other important organ diseases
- History of gastrointestinal bleeding within 3 months
- Unable to cooperate with ablation surgery
- Severe gastroesophageal varices
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06530784
Start Date
July 31 2024
End Date
May 31 2026
Last Update
July 31 2024
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032