NCT01470495Unknown不适用
Radiofrequency Ablation Plus Sorafenib Administration in Early Recurrent Hepatocellular Carcinoma: a Prospective Multicenter Cohort Trial (Repeat) Tumors for BCLC B Stage HCC Undergone Curative Hepatectomy
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- time interval between new lessions emerging after the first HCC recurrence
研究概览
简要总结
RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recurrent HCC after curative resection
- •without gender restriction
- •age between 18 to 75 years
- •The liver function showed no worse than Child-Pugh B
- •tumor nodes were less than 5cm and no more than 3 nodules
排除标准
- •Pregnancy patients
- •With extrahepatic tumor or lymphnode metastasis
- •Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
结局指标
主要结局
time interval between new lessions emerging after the first HCC recurrence
时间窗: 3 year
次要结局
- 3-year overrall survival(3 year)
研究者
feng xiaobin
Institute of hepatobiliary surgery,southwest hospital
Southwest Hospital, China
研究点 (1)
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