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) in Subjects with Advanced Triple Negative Breast Cancer. Subjects with advanced Triple Negative Breast Cancer will be recruited. Patients will be randomised to two treatment arms of this study. One arm is SHR-1210 combination with apatinib daily dosing, and the other arm is SHR-1210 combination with apatinib intermittent dosing; each arm will enrolle10-29 subjects (Simons two stage design). This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in the treatment of advanced TNBC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.
Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
ORR
Overall Response Rate
Time frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
Incidence of Treatment-Emergent Adverse Events
adverse events/serious adverse events
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
DCR
Disease Control Rate
Time frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
DoR
Duration of response
Time frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
PFS
Progression-Free-Survival
Time frame: from the first drug administration up to the first occurrence of progression or death (up to about 5 years)
One year-OS
One year-Overall survival
Time frame: 12 months after the first drug administration
CBR
Clinical benefit rate
Time frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
TTR
Time to response
Time frame: from the first drug administration up to one year
Frequencies Of Biomarkers
Biomarkers (PD-L1, PD-1, VEGF-A, eg) in tumor tissue and peripheral blood
Time frame: pre-dose, and up to two years
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