Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
The objective of this study is to study the safety and tumor response of ACE for large HCC.
详细描述
Transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. Among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (cTACE), chemoembolization using drug eluting beads (DEB-TACE) and radioembolization using yttrium 90 is generally unsatisfactory. Some would consider HCC of size >10cm a relative contraindication for cTACE because of the poor treatment outcome. However, there is no better alternative treatment for local control of these tumors. Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of HCC as compared to cTACE in a case-control study. It is hypothesized that ACE is safe and effective for local control of large HCC of size >10cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signage of a written informed consent
- •Age above 18 years
- •HCC unsuitable for resection
- •Child-Pugh A or B cirrhosis
- •Eastern Cooperative Oncology Group performance score 0 or 1
- •No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
- •HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
- •No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
- •No invasion of portal vein or hepatic vein
- •Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)
- •Total tumor mass < 50% liver volume
- •Size of any individual tumor >10cm in largest dimension
排除标准
- •History of acute tumor rupture presenting with hemo-peritoneum
- •Biliary obstruction not amenable to percutaneous or endoscopic drainage
- •Child-Pugh C cirrhosis
- •History of hepatic encephalopathy
- •Intractable ascites not controllable by medical therapy
- •History of variceal bleeding within last 3 months
- •Serum total bilirubin level > 50 umol/L
- •Serum albumin level < 25g/L
- •Serum creatinine level > 150 mmol/L.
- •Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
- •Arterio-portal venous shunt affecting >1 hepatic segment on CT
- •Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
研究组 & 干预措施
ACE for HCC of size >10cm
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
干预措施: Ablative chemoembolization (ACE) (Procedure)
结局指标
主要结局
Time to progression
时间窗: 3 to 6 months after treatment
the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression
次要结局
- Tumor response(3 to 6 months after treatment)
研究者
Simon Yu
Professor
Chinese University of Hong Kong