NCT01498055Unknown不适用
A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease Control Rates (DCR)
研究概览
简要总结
To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.
详细描述
A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •18~70 year old, KPS score >50 points, estimate survival > 3 months;
- •Primary lung cancer patients after chemotherapy or radiation therapy;
- •Primary lung cancer patients after targeted therapy;
- •Primary lung cancer patients with lung function can not accept operation or unwilling to operation;
- •Primary lung cancer recurrence or surgery can't complete resection;
- •Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf, etc.);
- •No serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases;
- •Patients Voluntary attempt, and informed consent.
排除标准
- •History of cardiovascular disease: congestive heart failure > New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction;
- •Cachexia; or other deadly diseases;
- •Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
- •Active infection;
- •Pregnant or lactating women
- •At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);
- •Now or recently will join another experimental clinical study ;
- •Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, HIV infections, etc.), or influence on the results of clinical trials for analysis.
结局指标
主要结局
Disease Control Rates (DCR)
时间窗: From 12-2011 to 12-2013
Lung lesions of disease control rates DCR (CR + PR + SD), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST) standard
次要结局
- Overall Survival(OS)(2 years)
研究者
Gong Liang
MD
Third Military Medical University
研究点 (1)
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