triple negative breast cancer
Conditions
Interventions
experimental group:carrelizumab combined with albumin-binding paclitaxel
control group:Conventional treatment
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old. 2. Confirmed by histopathology as triple negative breast cancer (specific definition: IHC of ER = 3 months; 6. >= 4 weeks from the last cytotoxic drug, radiotherapy or operation; 7. The function of the main organs is normal: 1) HB >= 90g/L (no blood transfusion within 28 days); 2) ANC >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; 4) ALT and AST = 60 ml/min. 8. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up. 9. Women of childbearing age should agree that contraceptive measures (such as intrauterine device (IUD), contraceptive or condom) must be used during the study and within 6 months after the end of the study. Serum or urine pregnancy tests are negative within seven days before the study, and must be non-lactation patients.
Exclusion criteria
Exclusion criteria: 1. Has an autoimmune disease and has received systemic treatment in the past 2 years; 2. Diagnosis of immunodeficiency or treatment with systemic steroids or other forms of immunosuppression within 7 days; 3. Anti-pd-1, PD-L1 or another drug that directly ACTS on the inhibitory receptors on the surface of T cells (such as CTLA-4, Ox-40, CD137) were previously used; 4. Previously participated in any clinical study of Carrelizumab (SHR1210); 5. Has a history of abuse of psychotropic substances and cannot be relieved or has a mental disorder; 6. Known active brain metastases and/or cancerous meningitis; 7. Participated in other clinical trials of anti-tumor drugs within 4 weeks; 8. Decompensated patients with cardiac insufficiency or refractory hypertension (hypertensive patients whose systolic and diastolic blood pressure cannot be controlled at the target level after adequate dosage, reasonable combination of at least three antihypertensive drugs, including improved lifestyle and use of diuretics); An abnormal electrocardiogram (ECG) at screening that the investigator considers to be of clinical significance and may pose an unacceptable risk to the patient's participation in the study; 9. Patients with uncontrolled concomitant diseases, including but not limited to uncontrolled infection, congestive heart failure, unstable angina, arrhythmia, etc.; 10. Allergic constitution or multiple drugs, or allergic or intolerant to PD-1; 11. Concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study. 12. The researcher thinks that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactXiaoxiang Guan
Outcome results
None listed