NCT01884168已完成不适用
Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy
Capital Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Immunotherapy response
研究概览
简要总结
To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor presenting malignant cavity effusion after DC-CIK immunotherapy.
详细描述
- The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
- Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.
- The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
- The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
- Statistical analysis is performed using unsupervised hierarchical cluster.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed with malignant tumor and malignant cavity effusion.
- •An Eastern Cooperative Oncology Group（ECOG）performance status of 0-
- •Normal cardiac, hepatic, renal and bone marrow functions.
- •Life expectancy >3 months.
- •Not receive other anti-tumor treatment.
- •Not receive chemotherapy in pleural and abdominal cavity.
排除标准
- •Previous history of other malignancies.
- •Serious or uncontrolled concurrent medical illness.
结局指标
主要结局
Immunotherapy response
时间窗: 1 month
T-Cell Receptor and B-Cell Receptor gene expression profiling and the change of cytokines, lymphocytes subpopulation before and after DC-CIK infusion
次要结局
未报告次要终点
研究者
Jun Ren MD, PhD
Director
Capital Medical University
研究点 (1)
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