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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Fudan University Shangshai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGORR
The number of people with tumor responses according to RECIST (V1.1): the proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR).
Time frame: Up to 12 months
Duration of Response (DOR)
The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Time frame: Up to 12 months
Disease Control Rate (DCR)
The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).
Time frame: Up to 12 months
Progression-free Survival (PFS)
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Time frame: Up to 12 months
One-year overall survival (OS) rate
OS defined as the time from the date of randomization to the date of death due to any reason. One-year survival rate (percentage of subjects alive at 1 year) was estimated from OS data.
Time frame: Up to 12 months
Frequencies of Biomarkers
Time frame: Up to 12 months
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