NCT00261378已完成2 期
Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 34
- 主要终点
- Objective response rate measured according to RECIST and EASL
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Objective response rate measured according to RECIST and EASL
时间窗: 6 months
次要结局
- Cardiotoxicity(6 months)
- Health care resource use(6 months)
- Safety(6 months)
- Change in Alpha Fetal Protein (AFP) over time(6 months)
- Other procedures or interventions required(6 months)
- Local Tumour Response(6 months)
- Patient quality of life(6 months)
- Time to hospital discharge(6 months)
- Toxicity(6 month)
- Time To Progression(6 months)
研究者
研究点 (34)
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