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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 +Apatinib daily dosing | Experimental | SHR-1210 200mg(3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, daily dosing (d1-d14) |
|
| SHR-1210+Apatinib intermittent dosing | Experimental | SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, intermittent dosing(Continuous administration for 7 days every 14 days, d1-d7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate | from the first drug administration up to the first occurrence of progression or death(up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | adverse events/serious adverse events | from the first drug administration to within 90 days for the last SHR-1210 dose |
| DCR | Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erwei Song | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32448804 | Derived | Liu J, Liu Q, Li Y, Li Q, Su F, Yao H, Su S, Wang Q, Jin L, Wang Y, Lau WY, Jiang Z, Song E. Efficacy and safety of camrelizumab combined with apatinib in advanced triple-negative breast cancer: an open-label phase II trial. J Immunother Cancer. 2020 May;8(1):e000696. doi: 10.1136/jitc-2020-000696. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| Apatinib | Drug | Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared. |
|
| from the first drug administration up to the first occurrence of progression or death(up to 24 months) |
| DoR | Duration of response | from the first drug administration up to the first occurrence of progression or death(up to 24 months) |
| PFS | Progression-Free-Survival | 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 | 12 months after the first drug administration |
| CBR | Clinical benefit rate | from the first drug administration up to the first occurrence of progression or death(up to 24 months) |
| TTR | Time to response | 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 | pre-dose, and up to two years |
| D017437 |
| Skin and Connective Tissue Diseases |