A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC

Inclusion criteria

• The patients signed the written informed consent
• Women aged 18-70.
• The pathologic diagnosis of recurrent metastatic triple negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
• At least one measuring lesion that conforms to RECIST v1.1 standard.
• The number of chemotherapy lines in the metastatic phase was <3 line.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Have a life expectancy of at least 12 weeks.
• Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
• The patients can swallow pills.
• The results of patients' blood tests are as follows: • Hb≥90g/L; • Plt≥90E+9/L; • Neutrophils≥1.5E+9/L; • ALT and AST ≤ triple of normal upper limit; • TBIL ≤ 1.5 times of normal upper limit; • Creatinine ≤ 1.5 times of normal upper limit.

Exclusion criteria

• The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
• Subjects with severe allergic reactions to other monoclonal antibodies.
• The subjects had a central nervous system metastases with clinical symptoms.
• History of hypertension and antihypertensive medications are not well controlled.
• A heart condition or disease that is not well controlled.
• Subjects had active infections or recent treatment with a systemic immunostimulatory agent (received within the previous 4 weeks).
• Other clinical trials of drugs were used in the first four weeks of the first medication.
• Subjects with treatment history of anti-angiogenesis drugs or check-point inhibitors.