NCT03499834已完成2 期
A Phase II Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
In this study, whole blood is drawn from the patient to be used to grow Immune Killer Cells (IKC). After proliferation, the IKC will be infused back into the patient to treat the cancer for a total of 24 weekly treatments.
Possible adverse reaction can include slight fever and headache.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≧20 years old
- •Life expectancy≧3 months
- •Eastern Cooperative Oncology group (ECOG) score 0~2
- •Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC)
- •Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...
排除标准
- •Patients with history of cardiovascular disease, including uncontrolled hypertension, congestive heart failure, myocardial infarction, angina pectoris, coronary artery disease, uncontrolled arrhythmia , previous history of encephalopathy within the past six months of screening period
- •Patients with HIV, HTLV or active tuberculosis
- •Women who are pregnant or breast-feeding
- •Patients with drug or other substance abuse
- •Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)
研究组 & 干预措施
Study Group
Experimental
26 patients who has successfully undergone the screening criteria will be enrolled for treatment. Immune Killer Cells (IKC) will be administered through Intravenous Injection (I.V.) Frequency: One injection per week, twenty-four injections on-treatment
干预措施: Immune Killer Cells (IKC) (Biological)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 6 months
The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety](7 months)
- Quality of Life (QOL)(8 months)
研究者
研究点 (2)
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