NCT03564405已完成不适用
A Open, Single-arm, Uncontrolled, Single Center, Pilot Study to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Pilot Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 19 years
- •Diagnosis of HCC
- •Unresectable asymtomatic uninodular or multinodular tumor.
- •Subject who maintain clinically normal hepatopetal flow without main portal vein closure
- •At least one measurable target lesion by CT or MRI which 10 mm or more.
- •ECOG Performance Status of 0 or
- •Child-Pugh class A or B
- •Life expectancy of at least 6 months.
排除标准
- •Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
- •Hepatic resection, liver transplantation or Percutaneous local treatment
- •Previously received HCC related medical procedure
- •Previously treated with anthracyclines
- •Only measurable disease is within an area of the liver previously subjected to radiotherapy.
- •Child Pugh C
- •Active gastrointestinal bleeding within 6 months from screening.
- •Total bilirubin > 3mg/dL
- •WBC < 3,000cells/mm3
- •ANC < 1,500cells/mm3
- •Platelet < 50,000mm3
- •Serum creatinine > 2mg/dL
- •INR > 1.4
- •ALT and AST > 5 times UNL
- •Diffuse HCC defined as >50% tumor involvement of the whole liver.
研究组 & 干预措施
UNI-DEB
Experimental
干预措施: UNI-DEB (Device)
结局指标
主要结局
Objective Response Rate
时间窗: 4 weeks after treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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