NCT02693236Unknown1 期
Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
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: 2014年8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 rate 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) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher 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 esophagus cancer
- •Age >18 years at time of consent
- •Received standardized treatment of Small-Cell Lung Cancer
- •Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
- •KPS (Karnofsky performance scale) >60
- •Patient's written informed consent
- •No severe viral or bacterial infections
- •Predicted survival >3 months
排除标准
- •Serious dysfunction of vital organs(heart, liver or kidney)
- •History of autoimmune diseases
- •Pregnant and breast-feeding patient
- •Active or chronic infectious diseases
- •History of allergy or hypersensitivity to study product excipients
- •Currently participating in another clinical trial
- •Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
- •Clinically relevant diseases or infections (HBV, HCV, HIV)
结局指标
主要结局
objective rate response (CR+PR) as measured by RECIST criteria
时间窗: Time Frame: 4 weeks after DC/CIK treatment
次要结局
- number of participants with adverse events(Time Frame: 3 days within DC/CIK treatment)
研究者
研究点 (1)
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