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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cryoablation

    Procedure/Surgery

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: treatment groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

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

Time frame
Up to 2 years

Secondary outcomes

1

Time to progress

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

Time frame
Up to 2 years
2

Objective Response Rate

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

Time frame
Up to 2 years
3

Overall survival

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

Time frame
Up to 2 years
4

Adverse events

CTCAE v5.0 is used to assess adverse events.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: