NCT01821482Unknown2 期
A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Hepatocellular Carcinoma
Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progression-free survival(PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).
详细描述
About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 18 years of age;
- •Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;
- •Patients who have a life expectancy of at least 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
- •The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);
- •The ECG results were normal, and the liver and kidney were functional.
排除标准
- •Patients who had distant metastases;
- •Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- •Patients who were pregnant or lactating;
- •ECOG perform status ≥ 2;
- •Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
结局指标
主要结局
progression-free survival(PFS)
时间窗: 1 month
次要结局
- Overall survival(OS)(1 month)
- quality of life (QOL)(month)
研究者
Weiliang Sun
Investigator
Guangxi Medical University
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Study of DC-CIK to Treat Colorectal CancerColorectal CancerNCT01839539Guangxi Medical University60
已完成
1 期
Anti-PD-1 Alone or Combined With Autologous Cell Therapy in Advanced NSCLCNeoplasmsLung CancerNCT03360630Capital Medical University60
已完成
1 期
Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic CancerPancreatic CancerNCT01781520Capital Medical University47
Unknown
1 期
Study of DC-CTL Combined With CIK for Advanced Solid TumorLung CancerRenal Cell CarcinomaColorectal CancerNasopharyngeal CarcinomaNCT03047525Xiaoyi Huang200
已完成
1 期
Study of S-1 Plus DC-CIK for Patients With Advanced Gastric CancerGastric CancerNCT01783951Capital Medical University63