- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04303741
A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC
An Open-labeled, Single-arm, Investigator-initiated Phase II Trial of Camrelizumab (Anti-PD-1 Antibody) in Combination With Apatinib and Eribulin in Patients With Advanced Triple-Negative Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- The First Affiliated Hospital, Sun Yat-sen University
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Guangzhou, Guangdong, China, 510120
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Shanghai
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Shanghai, Shanghai, China, 200433
- Changhai Hospital, Navy Medical University (Second Military Medical University)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patients sign the written informed consent.
- Women aged 18-70.
- The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer [ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative(IHC-/+ or IHC++ and FISH/CISH-)]. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
- Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
- The patient can swallow pills.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- With a life expectancy of at least 12 weeks.
The results of patient's blood tests are as follows:
• Hb≥90g/L; • Plt≥100^9/L; • Serum albumin ≥3g/dL;• Neutrophils≥1.5^9/L; TSH≤ normal upper limit (ULN);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN); • TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);• AKP≤ 2.5 ULN; • Renal function within 7 days before the first administration: serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.
Exclusion Criteria:
- The subjects had a central nervous system metastases with clinical symptoms.
- Other clinical trials of drugs were used in the first four weeks before the first dose.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- Received other anti-tumor treatments within 28 days before the first dose.
- A heart condition or disease that is not well controlled.
- Subjects with treatment history of anti-angiogenesis drugs, or immunotherapy (previous use of anti-PD-1/PD-L1 antibodies was allowed) or eribulin.
- The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
- Subjects had history of hypertension and poor control with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- Urine routine indicated that urine protein ≥ ++, or the 24-hour urine protein quantity ≥ 1.0g.
- Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
- Congenital or acquired immune deficiency (such as HIV infection);
- Receive live vaccine within 4 weeks before or during the study period;
- Patients who are allergic to or contraindicated to the experimental drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Camrelizumab +Apatinib+Eribulin
Camrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv Q3W combination with Apatinib 250mg, po, daily (d1-d21)and Eribulin1.4mg/m2
iv d1, d8 Q3W
|
Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.
Patients received up to two years of treatment.
Apatinib 250mg will be administered daily until unacceptable toxic effects or disease progression or other termination criteria appeared.
Patients received up to two years of treatment.
Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared.
Patients received up to two years of treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: from the first drug administration up to the first occurrence of progression or death (up to 24 months)
|
The propotion of subjects with CR or PR.
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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 |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Time Frame: from the first drug administration to within 90 days for the last 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 dose
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Disease Control Rate (DCR)
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
|
The propotion of subjects with CR, PR, or SD.
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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 24 months)
|
Progression-Free-Survival
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from the first drug administration up to the first occurrence of progression or death (up to 24 months)
|
One year-OS rate
Time Frame: 12 months after the first drug administration
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One year-Overall survival rate
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12 months after the first drug administration
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Clinical benefit rate (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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The propotion of subjects with CR, PR, or SD for >=6 months during the study.
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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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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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Frequencies of Biomarkers
Time Frame: pre-treatment, up to 24 months
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Biomarkers (including tumor/stromal PD-L1, stromal PD-1, tumor-infiltrating lymphocytes and tumor-infiltrating B cells, eg)
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pre-treatment, up to 24 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
- Immuno2020-01
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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