The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.
详细描述
1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only S-1 and Bevacizumab (continuous) .
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
- •Patients who can accept curative operations 18-70 years old
- •Histologically confirmed with colorectal cancer at stage Ⅳ
- •Patients who can accept oral drugs;
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
排除标准
- •Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine 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
S-1 and Bevacizumab
S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer.
S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress.
CIK plus S-1 and Bevacizumab
Cytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab.
S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress.
Cytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress.
干预措施: Cytokine-Induced Killer Cells (Biological)
结局指标
主要结局
Overall Survival(OS)
时间窗: 3 months
次要结局
- Disease-free survival(3 months)