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

NCT06530784 | Not Yet Recruiting Phase 2

• 1 other identifier: ZS-IR-205R
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.

  Up to 2 years

Secondary Outcomes (4)

• Time to progress

  Up to 2 years

• Objective Response Rate

  Up to 2 years

• Overall survival

  Up to 2 years

• Adverse events

  Up to 2 years

Study Arms (1)

treatment group

EXPERIMENTAL

Cryoablation combined with PD-1 antibody and bevacizumab

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

Interventions

Cryoablation PROCEDURE

After the completion of screening, the subjects received cryoablation treatment

treatment group

PD-1 antibody and bevacizumab DRUG

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cryosurgery; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jian Zhou

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingxiao Liu

CONTACT

+86-18616881019; liulingxiao2022@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cryoablation combined with PD-1 antibody and bevacizumab

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 31, 2024
• Study Start: July 31, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (1)