A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) With Lipiodol-Ethanol Mixture (LEM) Versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 3
- 主要终点
- progression free survival
研究概览
简要总结
The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.
详细描述
The standard loco-regional treatment for unresectable hepatocellular carcinoma is transarterial chemoembolization (TACE). However, The drawback of conventional chemoembolization (TACE) for liver cancer is that it cannot effectively embolize portal venules supplying the tumors, therefore chemoembolization is difficult to completely eradicate the tumor. Usually multiple treatments are required and tumor recurrences are common.
Transarterial Ethanol Ablation (LEM) can potentially provide a better treatment outcome with fewer treatment sessions. Preliminary results from a clinical study showed that the complication rate is reduced while survival rate may be improved. This study aims to compare survival duration and response rate between the treatments TACE and LEM.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient factor
- •Age > 18
- •Child-Pugh A or B cirrhosis
- •ECOG performance status Grade 2 or below
- •No serious concurrent medical illness
- •No prior treatment (including surgery) for HCC
- •Tumor factor
- •Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
- •Unresectable and locally advanced disease without extra-hepatic disease
- •Massive expansive or nodular tumor morphology with measurable lesion on CT
- •Size of largest tumor <= 15cm in largest dimension
- •Number of main tumor <= 5, excluding associated small satellite lesions.
排除标准
- •Patient factor
- •History of prior malignancy except skin cancer
- •History of significant concurrent medical illness such as ischemic heart disease or heart failure
- •History of acute tumor rupture
- •Serum creatinine level > 180 umol/L
- •Presence of biliary obstruction not amenable to percutaneous drainage
- •Child-Pugh C cirrhosis
- •Evidence of poor liver function
- •History of hepatic encephalopathy, or
- •Intractable ascites not controllable by medical therapy, or
- •History of variceal bleeding within last 3 months, or
- •Serum total bilirubin level > 50 umol/L, or
- •Serum albumin level < 28g/L, or
- •INR > 1.3
- •Tumor factor
- •Presence of extrahepatic metastasis
- •Predominantly infiltrative lesion
- •Diffuse tumor morphology with extensive lesions involving both lobes.
- •Vascular complications
- •Hepatic artery thrombosis, or
- •Partial or complete thrombosis of the main portal vein, or
- •Tumor invasion of portal branch of contralateral lobe, or
- •Hepatic vein tumor thrombus, or
- •Significant arterioportal shunt not amenable to shunt blockage, or
- •Significant arteriovenous shunt not amenable to shunt blockage
结局指标
主要结局
progression free survival
时间窗: 3 years
overall survival
时间窗: 3 years
次要结局
- tumor response(4 weeks after end of treatment)
- consumption of hospital resources(3 years)
- toxicity of treatment(4 weeks after end of treatment)
- quality of life(up to one year after randomisation)
- rate of conversion to resectable stage(4 weeks after end of treatment)
研究者
Edwin P Hui
Consultant
Chinese University of Hong Kong