Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 主要终点
- overall survival
研究概览
简要总结
Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.
详细描述
To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes.
The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria were:
- •Not indicated for resection,
- •Liver function of Child-Pugh class A or B,
- •3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter,
- •No portal vein involvement or extrahepatic metastasis,
- •Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct,
- •Platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and
- •No previous HCC treatment.
排除标准
- •Exclusion criteria were:
- •Encephalopathy,
- •Refractory ascites,
- •Active gastrointestinal bleeding,
- •Renal failure.
结局指标
主要结局
overall survival
时间窗: 5 years
次要结局
- tumor response(1-6 months)