Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Survival rate of the subjects
研究概览
简要总结
The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
详细描述
Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •ECOG performance status 0-2
- •Hepatocellular carcinoma diagnosed histologically or clinically
- •Tumor numbers of 5 or less
- •No history of treatment for hepatocellular carcinoma
- •Patients with informed consent
排除标准
- •Extrahepatic metastasis
- •Rupture of hepatocellular carcinoma
- •Infiltrative hepatocellular carcinoma
- •Malignancy other than hepatocellular carcinoma
结局指标
主要结局
Survival rate of the subjects
时间窗: 24 months after TACE
Survival rate of the subjects, 24 months after TACE
次要结局
- Disease free survival of the subjects(6, 12, 18, and 24 months after TACE)
- Complication rate of TACE(6, 12, 18, and 24 months after TACE)