NCT05303038

Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic TNBC Patients Failed by Multiline Therapy

A Phase II Clinical Study of Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic Triple Negative Breast Cancer Patients Failed by Multiline Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label study evaluating the efficacy and safety of Cryoablation combined with Tirelizumab and Bevacizumab in liver metastatic triple-negative breast cancer patients failed by multiline therapy.

Detailed description

This is a prospective, single-arm, single-center phase II clinical trial in liver metastatic triple-negative breast cancer patients failed by multiline therapy. All subjects will receive cryoablation combined with tirelizumab + bevacizumab: 1. Cryoablation of liver metastases: Cryoablation of 1-2 typical metastatic lesions will be performed on D1 under general anesthesia and ultrasound guidance for two cycles. If the patient has no measurable lesions outside the liver, the measurable lesions should be retained after partial ablation of the liver lesions. 2. PD-1 antibody + anti vascular therapy: patients will receive 200mg Tirelizumab ( IV Q3W) + Bevacizumab 7.5mg/kg ( IV Q3W) at D14 after cryoablation until there is disease progression, intolerable toxic reaction, subject withdraws informed consent or the study ends (whichever comes first). 3. Puncture biopsy of liver metastases will completed 1-3 days before cryoablation, 1-3 days before the first treatment with tirelizumab + bevacizumab, 2 cycles after treatment with tirelizumab + bevacizumab and after disease progression, and blood samples (about 10ml) were collected for mutation load detection and immune function evaluation.

Conditions

• Metastatic Breast Cancer in the Liver

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cryoablation Combined with Tirelizumab and Bevacizumab	Cryoablation of 1-2 typical metastatic lesions will be performed on D1 under general anesthesia and ultrasound guidance for two cycles. 200mg Tirelizumab ( IV Q3W) + Bevacizumab 7.5mg/kg ( IV Q3W) will be administered at D14 after cryoablation.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2022-03-31
• Last updated: 2022-06-09

Locations

2 sites across 1 country: China