NCT02724332已完成1 期
A Randomized Controlled Study on the Effect of Adjuvant Anti-recurrence Treatment With Rapamycin on Early-stage HCC With Overexpression of ASPH After Radical Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.
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 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
- •Estimate tumor can gain treatment of curing operation
- •No evidence for extrahepatic metestasis
- •liver function ：Child-Pugh A/B
- •BCLC stage：0/1；TNM stage：Ⅰ
排除标准
- •reject to attend；
- •impossible to come to our hospital for physical examination regularly.
- •cancer epitome、seed focus、lymph node or distant metastasis
- •Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.
研究组 & 干预措施
transcatheter arterial chemoembolization
Active Comparator
Patients will be treated with TACE
干预措施: Rapamycin (Drug)
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
Eastern Hepatobiliary Surgery Hospital
研究点 (1)
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