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NCT Number: NCT06530784

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Cryoablation

Procedure

After the completion of screening, the subjects received cryoablation treatment

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.

Primary outcomes

  1. Progression-free survival

    Time frame: Up to 2 years

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

Secondary outcomes

  1. Time to progress

    Time frame: Up to 2 years

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

  2. Objective Response Rate

    Time frame: Up to 2 years

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

  3. Overall survival

    Time frame: Up to 2 years

    According to medical documents or descriptions of the patient's family

  4. Adverse events

    Time frame: Up to 2 years

    CTCAE v5.0 is used to assess adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Lingxiao Liu

CONTACT

[email protected]

+86-18616881019

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma After Progression of PD-1/L1 Antibody Treatment: a Pilot Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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