NCT02487017Unknown2 期
Phase 2 Study of DC-CIK Cells Combined With TACE in the Treatment of Hepatocellular Carcinoma
Shenzhen Hornetcorn Bio-technology Company, LTD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
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
Evaluation of DC-CIK cells combined TACE treatment for HCC
详细描述
60 patients with Hepatocellular Carcinoma, who had received Transcatheter Arterial Chemoembolization (TACE) , will be randomly divided into group A (receive DC-CIK+ TACE treatment) or group B (just receive TACE), and the randomize ratio will be 1:1.
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 Hepatocellular Carcinoma at stage I-II;
- •Patients who can accept Transcatheter Arterial Chemoembolization ;
- •Patients who have a life expectancy of at least 3 months;
- •Patients who have a Child-Pugh:A/B; .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
Transcatheter Arterial Chemoembolization
Sham Comparator
Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least.
干预措施: Transcatheter Arterial Chemoembolization (TACE) (Procedure)
DC-CIK
Experimental
After accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least.
干预措施: DC-CIK (Biological)
结局指标
主要结局
Overall survival
时间窗: 3 years
次要结局
- Progress-free survival(3 years)
- Quality of life (QOL)(3 years)
- Phenotypic analysis of T cells(1 years)
研究者
研究点 (1)
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