NCT00646100已完成4 期
Transarterial Chemoembolization Versus Best Support for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- survival rates
研究概览
简要总结
Transcatheter arterial chemoembolization (TACE) had been proved to improve the survivals for middle stage hepatocellular carcinoma (HCC), but for advanced stage HCC its' efficacy had not been proved. The investigators hypothesize that TACE also improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective control study to find out if the survivals for patients after TACE better than only best support or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- •Tumor size >7 cm with a portal vein invasion, and the tumor was considered to be unresectable
- •No previous HCC directed treatment
- •Eastern Co-operative Group performance status 0-1
- •Liver function: Child's A
排除标准
- •Avascular tumor
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •underlying serve cardiac or renal diseases
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Diffuse-type HCC
- •For patients with main portal vein occlusion, no adequate collateral circulation around the occluded portal vein
结局指标
主要结局
survival rates
时间窗: 6, 12 months
次要结局
- quality of life(6, 12 months)
研究者
Shi Ming
Professor
Sun Yat-sen University
研究点 (1)
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