Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Procedure: Cryoablation; Drug: PD-1 antibody and bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06530784

ZS-IR-205R

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

treatment group

Experimental group

Description:

Cryoablation combined with PD-1 antibody and bevacizumab

Treatment:

Drug: PD-1 antibody and bevacizumab

Procedure: Cryoablation