Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Extensive-Stage Small- Cell Lung Cancer: a Phase I/II Study

Affiliated Hospital to Academy of Military Medical Sciences0 个研究点目标入组 30 人开始时间: 2014年8月1日最近更新: 2016年2月23日

适应症

试验速览

阶段: 1 期
发起方
入组人数: 30
主要终点: objective rate response (CR+PR) as measured by RECIST criteria

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously preclinical research with DC 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 Small- Cell Lung 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

•Clinically relevant diseases or infections (HBV, HCV, HIV)
•Females who are pregnant or nursing
•Immunosuppressant treatment
•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 rate 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

发起方

Affiliated Hospital to Academy of Military Medical Sciences

申办方类型

Other

责任方

Sponsor

相似试验

Unknown

1 期

DC Vaccine Combined With CIK Cells in Patients With Renal Cell CarcinomaRenal Cell Carcinoma

NCT01924156Affiliated Hospital to Academy of Military Medical Sciences30

Unknown

1 期

Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone MetastasesNon-Small-Cell Lung Cancer With Bone Metastases

NCT02688686Affiliated Hospital to Academy of Military Medical Sciences30

招募中

1 期

DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AMLHigh-risk Soft Tissue Sarcoma

NCT01898663Affiliated Hospital to Academy of Military Medical Sciences30

尚未招募

2 期

DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in TreatingRenal Neoplasma

NCT02487550The First People's Hospital of Changzhou1,200

已完成

1 期

Autologous Dendritic Cell Vaccine in HIV1 InfectionHIV Infections

NCT00510497Sharon Riddler11