NCT02602938Unknown2 期
Aspirin on CTCs of Advanced Breast and Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intervention completed
研究概览
简要总结
The purpose of this study is to determine whether Aspirin could affect the number and subtype of circulating tumor cells of metastatic breast cancer and colorectal cancer.
详细描述
BACKGROUND:
- Invasion and metastasis are the main reason of death in metastatic cancer, and abundant evidence find circulating tumor cells(CTCs) take the core position in breast and colorectal cancer metastasis.
- Platelets play multiple role to facilitate the epithelial to mesenchymal transition of tumor cells and protect CTCs to survival in the circulation, which enrolled in the whole process of metastasis.
- Several clinical trials and observational study have validate the primary and secondary prevention effect of aspirin to both breast and colorectal cancer.
OBJECTIVES:
- Determine the effect of aspirin on CTC number of metastatic breast and colorectal cancer;
- Determine the effect of aspirin on CTC subtype (epithelial/mesenchymal/mixed type) of metastatic breast and colorectal cancer.
ELIGIBILITY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age from 18-75 years old.
- •Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
- •Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted.
- •Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
- •PS score ≤ 3
- •Anticipated survival time ≥ 3 months
- •CTCs≥5 / 7.5ml blood
排除标准
- •Allergic to aspirin or other types of non-steroid
- •History of hemorrhage of digestive tract or other hemorrhagic disease
- •Plan to receive surgery within the time frame of the trial
- •Medication history of aspirin or other types of anti-platelets drug within one months before the trial
- •Women in pregnant or lactation period
- •Any psychological or objective problem may influence the compliance of the patients
研究组 & 干预措施
aspirin
Experimental
- The included patients will be administered with aspirin (100mg) orally once a day in 28-day cycles.
- The CTC was evaluated at baseline, and every 28 days for 2 months.
干预措施: Aspirin (Drug)
结局指标
主要结局
Intervention completed
时间窗: 2 months
2-months follow-up completed and the CTCs' assessment was evaluated three times by Canpatrol technology, the tumor burden was evaluated by MRI or CT.
次要结局
- Disease progression(2 months)
研究者
Chao Ni
Dr.Ni
Zhejiang Provincial People's Hospital
研究点 (1)
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