Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).
详细描述
60 patients with stage Ⅲb～Ⅳ NSCLC will be randomly divided into group A（receive D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient who have singed the informed consent;
- •Histologically confirmed with NSCLC at stage Ⅲb～Ⅳ;
- •Expected survival time is more than 2 month;
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.
排除标准
- •Hemoglobin<8.0 g/dL,White blood cell <3 x 10^9/L;Platelet count <75 x 10^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times;
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- •Pregnant or lactating patients;
- •Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
- •Patients who are suffering from serious autoimmune disease;
- •Patients who had used long time or are using immunosuppressant;
- •Patients who had active infection;
- •Patients who are suffering from serious organ dysfunction;
- •Patients who are suffering from other cancer;
- •Other situations that the researchers considered unsuitable for this study.
研究组 & 干预措施
D-CIK
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
干预措施: Gemcitabine (Drug)
D-CIK
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
干预措施: Cisplatin (Drug)
D-CIK
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
干预措施: D-CIK (Biological)
Chemotherapy
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
干预措施: Gemcitabine (Drug)
Chemotherapy
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progress-free survival
时间窗: 3 years
次要结局
- Quality of life (QOL)(3 years)
- Phenotypic analysis of T cells(1 year)
- Severity of adverse events(1 year)
- Overall survival(3 years)