Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery
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
- Progress-free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).
详细描述
60 patients with stageⅠ~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.
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
- •18~80 years old;
- •Histologically confirmed with colorectal cancer at stage Ⅰ~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 - 1.
排除标准
- •Hemoglobin<8.0 g/dL,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;
- •History of organ allograft;
- •Patients who had distant metastases;
- •Patients who had active infection;
- •Prior use of any anti-cancer treatment in 30 days;
- •Now or recently will join another experimental clinical study ;
- •Other situations that the researchers considered unsuitable for this study.
研究组 & 干预措施
Chemo-radiotherapy
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
干预措施: Radiotherapy (Radiation)
Chemo-radiotherapy
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
干预措施: Chemotherapy (Drug)
DC-CIK
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.
干预措施: DC-CIK (Biological)
DC-CIK
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.
干预措施: Radiotherapy (Radiation)
DC-CIK
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progress-free survival
时间窗: 3 years
次要结局
- Overall survival(3 years)
- Quality of life (QOL)(3 Years)
- Phenotypic analysis of T cells(1 year)