Status:
UNKNOWN
Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic TNBC Patients Failed by Multiline Therapy
Lead Sponsor:
Fudan University
Conditions:
Metastatic Breast Cancer in the Liver
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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 m...
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...
Eligibility Criteria
Inclusion
- Histologically or Imageologically confirmed liver metastatic tnbc patients;
- Histologically confirmed diagnosis of TNBC characterized by estrogen receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
- ≥ 2 prior lines systemic therapy;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1);
- The patients show no signs of bile duct obstruction, and the bilirubin is below the upper limit of 1.5x normal value (ULN);
- Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- The functions of the patient's organs and blood system meet the requirements;
- Blood system function: absolute neutrophil count (ANC) ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L
- Renal function: estimated glomerular filtration rate or creatinine clearance \> 50 ml / min / 1.73 M2
- Liver function: total bilirubin ≤ 1.5 x ULN, AST and alt ≤ 5 x ULN
- Estimated survival time ≥12 weeks.
Exclusion
- The patient is currently receiving or has received irradiation or local treatment for the target lesion in the past 3 weeks.
- The patient had previously received cryoablation.
- The patient received major surgery within 14 days before enrolling in the study.
- Palliative radiotherapy must be completed at least 2 weeks before enrolling in the study, and there is no plan for additional radiotherapy for the same lesion; ·Patients whose AE caused by radiotherapy did not recover to ≤ CTCAE 1 degree
- The patient had metastatic brain lesions, including asymptomatic and well controlled lesions.
- Complicated with infection and requiring intravenous antibiotic treatment.
- The patient has any clinically significant disease or history that the investigator believes may endanger the safety of the patient or the reliability of the study results.
- The patient has a history of any other malignancy unless the remission period exceeds 1 year. (do not exclude skin cancer, cervical cancer in situ, superficial bladder cancer, and breast cancer in radical treatment).
- Female patients are pregnant or breastfeeding.
- The patient received any trial drug within 14 days before receiving the first study drug.
- The patient had undiminished or unstable severe toxicity (≥ CTCAE 4.0 grade 2) after previous use of another trial drug and / or previous cancer treatment, except anemia, weakness and hair loss.
- Patients are allergic to the test drug or any of its excipients.
- Patients are known to be HIV positive, have HCB, or have HBV infection and HBV DNA exceeds 2000 IU / ml.
- The patient has a known history of drug addiction in the past 1 year, because this situation may lead to a high risk of non-compliance of the trial drug.
- The patient has known active or suspected autoimmune disease. Subjects who are in a stable state and do not need systemic immunosuppressive therapy are allowed to be enrolled.
- Subjects requiring systemic treatment with corticosteroids (\> 10mg / day prednisone efficacy dose) or other immunosuppressants within 14 days before the administration of the study drug were allowed to inhale or locally use steroids and adrenal hormone replacement with a dose \> 10mg / day prednisone efficacy dose in the absence of active autoimmune diseases.
- The patient had a baseline corrected QT interval QTc \> 450 ms, or the patient had known QT prolongation syndrome, torsade de pointe ventricular tachycardia, symptomatic ventricular tachycardia, unstable heart syndrome within 3 months before the screening visit, \> grade 2 New York Heart Association heart failure, \> grade 2 Canadian Cardiovascular Association angina pectoris.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05303038
Start Date
May 1 2022
End Date
April 1 2024
Last Update
June 9 2022
Active Locations (2)
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1
Fudan University Shangshai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
2
Fudan University Shanghai Cancer Center
Shanghai, China