NCT02837757终止不适用
Everolimus Modulation of Anti-tumor T CD4 Immune Responses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Change in regulatory T cell counts during treatment with everolimus
研究概览
简要总结
Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with metastatic renal cell carcinoma.
The objective of this study is to investigated the influence of everolimus immune modulation on antitumor efficacy .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Performance status ECOG-WHO 0, 1 or 2
- •Metastatic renal cancer
- •Patient candidate to everolimus treatment
- •signed written informed consent
- •fertile women with adequate contraception during the study and until 8 weeks after stopping treatment
排除标准
- •Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
- •History of immune deficiency
- •Hypersensitivity against rapamycin and derived
- •Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
- •Active autoimmune diseases, HIV, hepatitis C or B virus
- •Patients with any medical or psychiatric condition or disease,
- •Patients under guardianship, curatorship or under the protection of justice.
研究组 & 干预措施
Biological samples
Experimental
Blood samples will be realized specifically to the study at inclusion (baseline before starting everolimus treatment), and then 3 months and 9 months (or at disease progression if occurs first) after initiation of everolimus treatment Peripheral blood mononuclear cell (PBMC) and serum will be collected.
Available tumor tissues samples will be collected.
干预措施: Biological samples (Other)
结局指标
主要结局
Change in regulatory T cell counts during treatment with everolimus
时间窗: 9 months after everolimus initiation
次要结局
未报告次要终点
研究者
研究点 (3)
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