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

Phase 2

Not yet recruiting

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: Cryoablation; Drug: PD-1 antibody and bevacizumab

• Registration Number: NCT06530784
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study Start: 2024-07-31
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	PD-1 antibody and bevacizumab	Cryoablation combined with PD-1 antibody and bevacizumab
treatment group	Cryoablation	Cryoablation combined with PD-1 antibody and bevacizumab

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 2 years	mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Time to progress	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
Objective Response Rate	Up to 2 years	mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
Adverse events	Up to 2 years	CTCAE v5.0 is used to assess adverse events.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China