NCT02688686Unknown1 期
Safety and Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases: a Phase I/II Study
Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年2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
- 1
- 主要终点
- objective response rate (CR+PR) as measured by RECIST criteria
研究概览
简要总结
The purpose 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 Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed diagnosis of non-small cell lung cancer
- •Age >18 years at time of consent
- •Received standardized treatment of Non-Small-Cell Lung Cancer with bone metastases
- •KPS (Karnofsky performance scale) >60
- •Patient's written informed consent
- •No severe viral or bacterial infections
- •Predicted survival >3 months
排除标准
- •Clinically relevant diseases or infections (HBV, HCV, HIV)
- •Females who are pregnant or nursing
- •Immunosuppressant treatment
- •Currently participating in another clinical trial
结局指标
主要结局
objective response rate (CR+PR) as measured by RECIST criteria
时间窗: one month after DC/CIK treatment
次要结局
- number of participants with adverse events(3 days during DC/CIK treatment])
研究者
研究点 (1)
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