Camrelizumab in Combination With PLD and Losartan in Patients With TNBC Who Have Received ≦ 1 Line of Chemotherapy
NCT ID: NCT05097248
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
52 participants
INTERVENTIONAL
2021-10-31
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Camrelizumab, Liposomal doxorubicin and Losartan
Participants receive intravenous camrelizumab (200 mg, Q3W) and liposomal doxorubicin (40 mg, Q3W for 6 weeks) plus oral losartan (50 mg loading dose followed by 100 mg QD, Q3W, until discontinuation of liposomal doxorubicin).
Camrelizumab
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.
Liposomal Doxorubicin
Liposomal Doxorubicin 40 mg/m2 on D1 every 3 weeks; 6 cycles are planned to be completed or discontinued due to intolerable toxicity or progression.
Losartan
Losartan will be orally administered at 50 mg for three days and increased to 100 mg if tolerated until the whole course of chemotherapy; if not tolerated, it will be maintained at 50 mg until the whole course of chemotherapy
Interventions
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Camrelizumab
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.
Liposomal Doxorubicin
Liposomal Doxorubicin 40 mg/m2 on D1 every 3 weeks; 6 cycles are planned to be completed or discontinued due to intolerable toxicity or progression.
Losartan
Losartan will be orally administered at 50 mg for three days and increased to 100 mg if tolerated until the whole course of chemotherapy; if not tolerated, it will be maintained at 50 mg until the whole course of chemotherapy
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. 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.
4. With a life expectancy of at least 12 weeks.
5. The cumulative dose of prior doxorubicin and epirubicin should not exceed 300 mg/m2 and 600 mg/m2, respectively, with randomization \> = 12 months since last treatment.
6. Previously treated with no more than one line of chemotherapy in the advanced setting.
7. PD-L1 positive, CPS score ≥ 1.
8. At least one measurable lesion according to RECIST 1.1;
9. The functional level of major organs must meet the following requirements:
1. blood routine: neutrophil (ANC)≥1.5×10\^9/L; platelet count (PLT)≥90×10\^9/L; hemoglobin (Hb) ≥90 g/L;
2. blood biochemistry: total bilirubin (TBIL)≤upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; alkaline phosphatase ≤ 2.5×ULN; blood urea nitrogen (BUN) and creatinine (Cr)≤1.5×ULN;
3. coagulation: international normalized ratio (INR) or prothrombin time (PT)≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.
4. Heart: left ventricular ejection fraction (LVEF)≥50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA).
5. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included.
10. 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.
11. The patient can swallow pills.
12. The patients sign the written informed consent.
Exclusion Criteria
2. Other clinical trials of drugs were used in the first four weeks before the first dose.
3. Subjects with severe allergic reactions to other monoclonal antibodies.
4. Received other anti-tumor treatments within 28 days before the first dose.
5. A heart condition or disease that is not well controlled.
6. Subjects with treatment history of anti-angiogenesis drugs, or immunotherapy (previous use of anti-PD-1/PD-L1 antibodies was allowed) or eribulin.
7. The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
8. Subjects had history of hypertension and poor control with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥100 mmHg)；
9. Subjects must not have baseline hypotension, defined as systolic blood pressure less than 100 mmHg in both readings taken 2 days prior to the study.
10. Urine routine indicated that urine protein ≥ ++, or the 24-hour urine protein quantity ≥ 1.0g.
11. Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
12. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
13. Receive live vaccine within 4 weeks before or during the study period;
14. Patients who are allergic to or contraindicated to the experimental drugs.
15. Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.
18 Years
70 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
INDUSTRY
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Yanxia Zhao
Director of the Department of Breast Oncology
Principal Investigators
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Yanxia Zhao, M.D.
Role: STUDY_CHAIR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Yanxia Zhao, M.D.
Role: primary
Other Identifiers
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WHUH-BC-001
Identifier Type: -
Identifier Source: org_study_id