Phase II Clinical Study of Patients Randomized, Open, Controlled Evaluation of Autologous Tumor Tissue Antigen Sensitized DC-CIK Cells Combined With Chemotherapy in the Treatment of Patients With Esophageal Resection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer
详细描述
60 patients of esophageal cancer with TNM stage of tumor stage II-III,who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive cancer tissue antigen sensitized D-CIK immune cells in combination with chemotherapy treatment) or group B (just receive chemotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous antigen-sensitized DC-CIK cells treatment (every 4 weeks) and chemotherapy. Patients in group B will receive only 3 cycles chemotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old;
- •Clinical diagnosis of esophageal cancer patients,tumor TNM stageII-III;
- •Patients who can accept curative operations;
- •Patients who have a life expectancy of at least 3 months; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.
排除标准
- •White blood cell <3 x 10^9/L,Platelet count <75 x 10^9/L;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;
- •Prior use of any anti-cancer treatment in 30 days;
- •Now or recently will join another experimental clinical study ;
- •History of organ allograft;
- •Other situations that the researchers considered unsuitable for this study
研究组 & 干预措施
DC-CIK
After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.
干预措施: Paclitaxel (Drug)
DC-CIK
After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.
干预措施: DC-CIK (Biological)
DC-CIK
After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.
干预措施: Cisplatin (Drug)
Chemotherapy
After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.
干预措施: Paclitaxel (Drug)
Chemotherapy
After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: 3 years
The time of randomization begins to cause the death of any cause
次要结局
- Progress-free survival(3 years)
- Quality of life (QOL)(3 years)
- Phenotypic analysis of T cells(1 year)