- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394287
A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC
A Phase II, Open-labeled, Randomised, Non-comparative, Two-arms Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib in Subjects With Advanced Triple Negative Breast Cancer
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-1210 +Apatinib daily dosing
SHR-1210 200mg(3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, daily dosing (d1-d14)
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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.
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Experimental: SHR-1210+Apatinib intermittent dosing
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)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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Overall Response Rate
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from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TTR
Time Frame: from the first drug administration up to one year
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Time to response
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from the first drug administration up to one year
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Incidence of Treatment-Emergent Adverse Events
Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose
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adverse events/serious adverse events
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from the first drug administration to within 90 days for the last SHR-1210 dose
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DCR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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Disease Control Rate
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from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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DoR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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Duration of response
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from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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PFS
Time Frame: from the first drug administration up to the first occurrence of progression or death (up to about 5 years)
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Progression-Free-Survival
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from the first drug administration up to the first occurrence of progression or death (up to about 5 years)
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One year-OS
Time Frame: 12 months after the first drug administration
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One year-Overall survival
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12 months after the first drug administration
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CBR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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Clinical benefit rate
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from the first drug administration up to the first occurrence of progression or death(up to 24 months)
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Frequencies Of Biomarkers
Time Frame: pre-dose, and up to two years
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Biomarkers (PD-L1, PD-1, VEGF-A, eg) in tumor tissue and peripheral blood
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pre-dose, and up to two years
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Collaborators and Investigators
Investigators
- Principal Investigator: Erwei Song, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1210-APTN-IIT-TNBC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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