NCT01906632已完成不适用
Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy
Capital Medical University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- T-Cell Receptor/B-Cell Receptor gene expression
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 after DC-CIK immunotherapy.
详细描述
- The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
- Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing.
- The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
- Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy.
- Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.
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 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;
- •Age: 18-80 years;
- •an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •At least one measurable lesion according to the RECIST criteria;
- •Adequate bone marrow, cardiac, liver, and renal function;
- •Life expectancy ≥2 months;
- •Not received other anti-tumor treatment
- •Informed consent signed
排除标准
- •previous history of other malignancies;
- •Uncontrolled central nervous system metastases;
- •Serious or uncontrolled concurrent medical illness.
结局指标
主要结局
T-Cell Receptor/B-Cell Receptor gene expression
时间窗: 3 month
次要结局
未报告次要终点
研究者
Jun Ren MD, PhD
Director, Capita Medical University Cancer Center
Capital Medical University
研究点 (2)
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