NCT02587884Unknown1 期
Anti-recurrence Treatment of Postresection on Hepatocellular Carcinoma Patients With Microvascular Invasion Presence and Over-expression of Aspartate Beta-hydroxylase: A Randomized Controlled Study
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on the prognosis of patients with microvascular invasion presence(MVI) and overexpression of Aspartate-β-hydroxylase(ASPH).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Via clinical diagnosis and confirm it is primary liver cancer
- •Pathological evidence of HCC
- •Confirm presence of MVI and over-expression of ASPH after opreation
- •Within Milan criteria
- •Estimate tumor can gain treatment of curing operation
- •No evidence for extrahepatic metestasis
- •liver function ：Child-Pugh A/B
排除标准
- •Reject to attend
- •Impossible to come to our hospital for physical examination regularly
- •Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction
- •Female with pregnancy or during the lactation period
结局指标
主要结局
Overall Survival
时间窗: 3 years
次要结局
- Time to recurrence(3 years)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospital Affiliation: Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
研究点 (1)
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