Status:
COMPLETED
A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
This is a Phase II, Open-labeled, Randomised, Parallel, Non-comparative, Two-arms, Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03394287
Start Date
January 10 2018
End Date
September 30 2020
Last Update
October 23 2020
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120