Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.
详细描述
The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.
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
- Single (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
- •patients diganosed with hepatocellualr carcinoma beyond Milan criteria
- •the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
- •Child-Pugh A or B
- •ECOG score 0-1;
- •prothrombin time ≤16 s;
- •white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl
排除标准
- •expected survival time < 12 months before random assignment;
- •received anticancer surgery or procedure within one month before assignment;
- •concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
- •existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
- •upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.
研究组 & 干预措施
TACE group
Transcatheter arterial chemoembolization
干预措施: Transcatheter arterial chemoembolization (Device)
TACE+RFA/MV group
Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
干预措施: Transcatheter arterial chemoembolization (Device)
TACE+RFA/MV group
Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
干预措施: radiofrequency ablation/microwave ablation (Device)
结局指标
主要结局
overall survival
时间窗: up to 46 months
次要结局
- objective response rate(up to 46 months)