Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- survival time
研究概览
简要总结
Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages, tumour resection or liver transplantation are therapeutic options; later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation (PEI), transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized study investigates the effect of PEI on survival of patients with HCC. All patients will receive hormonal treatment (long-acting somatostatin intramuscularly [i.m.]) and will be randomized for treatment with PEI or no additional treatment.
详细描述
This is a randomized two-arm parallel group study.
- Study group: PEI + long-acting somatostatin
- Control group: long-acting somatostatin alone
Aims of the study:
- Does treatment with PEI+ long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone?
- Can time to tumour progression be extended in patients treated with PEI + long-acting somatostatin as compared to treatment with long-acting somatostatin alone?
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-proven hepatocellular carcinoma
- •Treatable with percutaneous ethanol instillation
- •Inoperable tumour
- •Age 18-85 years
排除标准
- •Liver cirrhosis Child C
- •Tumour diameter > 8 cm
结局指标
主要结局
survival time
time to tumour progression
次要结局
- quality of life
- causes of death
