NCT05670925招募中2 期
The Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib With/Without Nab-paclitaxel, of Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer：An Open, Single-arm, Multicenter Phase II Clinical Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of 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 ;
研究组 & 干预措施
Camrelizumab plus Famitinib with/without nab-palitaxel
Experimental
干预措施: Camrelizumab plus Famitinib with/without nab-Palitaxel (Drug)
结局指标
主要结局
PFS
时间窗: max 24 months
Progression Free Survival
次要结局
- ORR(8 WEEKS)
研究者
研究点 (1)
Loading locations...
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