NCT02449109已完成1 期
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma：Clinical Trial
Fuda Cancer Hospital, Guangzhou1 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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of nano drug（Gemzar® mix with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction angiography（DSA） for liver cancer.
详细描述
By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（DSA）for liver cancer.
The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's size is detected by laser diffraction particle size analyzer.
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
- •Karnofsky performance status >60
- •Diagnosis of liver cancer based on histology or the current accepted radiological measures.
- •Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- •Will receive interventional therapy
- •Life expectancy: Greater than 3 months
- •Patients' routine blood test, liver function and kidney function have no obvious abnormalities
- •Ability to understand the study protocol and a willingness to sign a written informed consent document
排除标准
- •Patients with other primary tumor except liver cancer
- •History of coagulation disorders or anemia
结局指标
主要结局
Number of participants with Adverse events
时间窗: 1 year
次要结局
- Percentage of lesions that show no sign of recurrence 12 months after interventional therapy(1 year)
- Progress free disease (PFS)(1 year)
- Overall survival (OS)(1 year)
研究者
研究点 (1)
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