NCT04129996Unknown2 期
Camrelizumab in Combination With Nab-paclitaxel and Famitinib as a First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer: An Open, Single-arm, Multicenter, Efficacy and Safety Phase II Clinical Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety of camrelizumab in combination with nab-paclitaxel and famitinib in Patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast Cancer..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 0-1
- •Expected lifetime of not less than three months
- •Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- •Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
- •Adequate hematologic and end-organ function, laboratory test results.
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
- •Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
排除标准
- •Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
- •A history of bleeding, any serious bleeding events.
- •Important blood vessels around tumors has been infringed and high risk of bleeding.
- •Coagulant function abnormality
- •artery/venous thromboembolism event
- •History of autoimmune disease
- •Positive test for human immunodeficiency virus
- •Active hepatitis B or hepatitis C
- •Uncontrolled pleural effusion and ascites
- •Known central nervous system (CNS) disease.
- •Long-term unhealing wound or incomplete healing of fracture
- •urine protein ≥2+ and 24h urine protein quantitative > 1 g.
- •Pregnancy or lactation.
- •Thyroid dysfunction.
- •Peripheral neuropathy grade ≥
- •People with high blood pressure;
- •A history of unstable angina;
- •New diagnosis of angina pectoris.
- •Myocardial infarction incident ;
- •Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency
研究组 & 干预措施
camrelizumab in combination with nab-paclitaxel and famitinib
Experimental
干预措施: camrelizumab in combination with nab-paclitaxel and famitinib (Drug)
结局指标
主要结局
ORR
时间窗: Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Participants
次要结局
未报告次要终点
研究者
Zhimin Shao
clinical professor
Fudan University
研究点 (1)
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