Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma
NCT ID: NCT06530784
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-07-31
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group
Cryoablation combined with PD-1 antibody and bevacizumab
Cryoablation
After the completion of screening, the subjects received cryoablation treatment
PD-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.
Interventions
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Cryoablation
After the completion of screening, the subjects received cryoablation treatment
PD-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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Jian Zhou
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Mengjie Yang
Role: primary
Other Identifiers
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ZS-IR-205R
Identifier Type: -
Identifier Source: org_study_id