A Multicentre, Open-parallel, Randomized, Controlled Phase Ⅲ Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).
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
- •ECOG Performance Status of 0-
- •Expected lifetime of not less than three months
- •Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- •Cancer stage: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection.
- •No prior systemic antitumor therapy for metastatic triple-negative breast cancer.
- •Adequate hematologic and organ function
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
排除标准
- •Known central nervous system (CNS) disease.
- •Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody.
- •A history of bleeding, any serious bleeding events.
- •Uncontrolled pleural effusion, pericardial effusion.
- •Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
- •History of interstitial pneumonitis.
- •Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB, etc.
- •Prior allogeneic stem cell or solid organ transplantation.
- •History of autoimmune disease
- •Active hepatitis B or hepatitis C
- •Pregnancy or lactation.
- •Peripheral neuropathy grade ≥
- •Participants with poor blood pressure control;
- •Myocardial infarction incident within 6 months prior to randomisation;
- •Treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation
- •Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation
研究组 & 干预措施
Experimental A
Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle
干预措施: Carelizumab (Drug)
Experimental A
Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle
干预措施: Nab-paclitaxel (Drug)
Experimental A
Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle
干预措施: Apatinib (Drug)
Experimental B
Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle
干预措施: Carelizumab (Drug)
Experimental B
Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle
干预措施: Nab-paclitaxel (Drug)
Comparator C
Subjects receive nab-paclitaxel intravenously each 4-week cycle.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months)
Progression-free survival (PFS) as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in PD-L1 positive / ITT population
次要结局
- Percentage of Participants with Adverse Events (AEs)(Up to approximately 42 months)
- Overall Survival (OS) in PD-L1 positive/ITT population(Up to approximately 42 months)
- Serum concentration of SHR-1210 and plasma concentration of apatinib(Up to approximately 42 months)
- Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline(Up to approximately 42 months)
- Clinical benefit rate (CBR), defined as the proportion of patients with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1(Up to approximately 42 months)
- Progression Free Survival (PFS)(Up to approximately 42 months)
- Objective response rate (ORR) in the PD-L1-positive/ITT population(Up to approximately 42 months)