NCT00396682已完成3 期
Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Frequency of CD4+CD25+regulatory T cells
研究概览
简要总结
It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+ regulatory T cells. These cells might suppress tumor-specific immune responses. Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses in patients with advanced HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adequate WBC
- •adequate liver and kidney function
- •no immunodeficiency
- •ECOG < 2
排除标准
- •advanced liver cirrhosis
- •severe cardiopulmonary diseases
结局指标
主要结局
Frequency of CD4+CD25+regulatory T cells
时间窗: within 8 weeks
Tumor specific immune responses
时间窗: within 12 weeks
次要结局
- Toxicity(within 8 weeks)
- Function and Phenotype of CD4+CD25+ regulatory T cells(within 12 weeks)
- Tumor response(within 12 weeks)
- Survival(6 months)
研究者
研究点 (2)
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