NCT01924156Unknown1 期
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study
Affiliated Hospital to Academy of Military Medical Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- objective tumor response (CR+PR) as measured by RECIST criteria
研究概览
简要总结
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years at time of consent
- •Histopathologically confirmed diagnosis of renal cell carcinoma
- •Received standardized treatment of renal cell carcinoma
- •Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
- •KPS (Karnofsky performance scale) >60
- •Patient's written informed consent
- •Predicted survival >3 months
- •No severe viral or bacterial infections
排除标准
- •Receiving chemotherapy, radiotherapy or other therapy
- •Patients with other malignancies and infectious diseases
- •Pregnant and breast-feeding patient
- •Currently participating in another clinical trial
- •Unfit for participating in this clinical trial in investigators' opinions
结局指标
主要结局
objective tumor response (CR+PR) as measured by RECIST criteria
时间窗: 4 weeks after DC/CIK treatment
次要结局
- number of participants with adverse events(3 days within DC/CIK treatment)
研究者
研究点 (2)
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