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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients signed the written informed consent
- •Women aged 18-
- •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 ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: SHR-1210 (Drug)
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)
干预措施: Apatinib (Drug)
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)
干预措施: SHR-1210 (Drug)
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)
干预措施: Apatinib (Drug)
结局指标
主要结局
ORR
时间窗: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
Overall Response Rate
次要结局
- DCR(from the first drug administration up to the first occurrence of progression or death(up to 24 months))
- One year-OS(12 months after the first drug administration)
- CBR(from the first drug administration up to the first occurrence of progression or death(up to 24 months))
- TTR(from the first drug administration up to one year)
- Incidence of Treatment-Emergent Adverse Events(from the first drug administration to within 90 days for the last SHR-1210 dose)
- DoR(from the first drug administration up to the first occurrence of progression or death(up to 24 months))
- PFS(from the first drug administration up to the first occurrence of progression or death (up to about 5 years))
- Frequencies Of Biomarkers(pre-dose, and up to two years)
研究者
Erwei Song, M.D., Ph.D.
President of Sun Yat-sen Memorial Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University