NCT02743065Unknown不适用
Superselective Drug-Eluting Chemoembolization With HepaSphere in Unresectable Advanced HCC Patients: Safety & Efficacy Registry in China (SUPER-China)
Fifth Affiliated Hospital, Sun Yat-Sen University6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this multicenter registry is to gather the safety, efficacy and survival data in advanced HCC patients treated with HepaSphere in China in order to evaluate the application of HepaSphere deTACE in treating advanced HCC patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 or older
- •Patient has signed informed consent
- •Patient must have a diagnosis of hepatocellular cancer by at least one of the following method:
- •Histological confirmation
- •Classic imaging characteristics of HCC: Early enhancement (Arterial hypervascularity) and Venous or Delayed phase washout in multidetector contrast enhanced computed tomography (CT) scan / dynamic contrast-enhanced magnetic resonance imaging (MRI) imaging.
- •Either CT/ MRI shows at least one solid liver lesion ≥ 2 cm with the above described imaging characteristics of HCC.
- •In case of liver lesion between 1 and 2 cm, both CT and MRI imaging have to be performed in order to confirm the imaging characteristics of HCC.
- •At time of study entry.
- •Patients not suitable for ablation due to lesion location may be enrolled
- •Patients with HCC recurrence but not suitable for resection or ablation maybe enrolled
- •Patient MUST be with BCLC stage C and meet the following criteria:
- •Stage Child-Pugh A or B AND
- •Performance status ECOG ≤ 2 WITH Vascular Invasion or WITHOUT Vascular invasion
- •Patient has a life expectancy of at least 6 months
排除标准
- •Current or previous treatment with chemo- or radiation therapy or sorafenib
- •Previous treatment of transarterial chemoembolization (TACE)
- •Patients with current or history of any other cancer except non-melanomatous skin cancer
- •Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
- •Performance status ECOG > 2
- •Child-Pugh Class C
- •Occlusive tumor thrombus to the main portal trunk
- •Active gastrointestinal bleeding
- •Evidence of uncorrectable bleeding diathesis
- •Extra-Hepatic spread of the HCC
- •>50% tumor involvement of the liver
- •Infiltrative HCC
- •Encephalopathy not adequately controlled medically
- •Presence of ascites not controlled medically
- •Any contraindication for MRI/ CT (eg. metallic implants)
- •Allergy to contrast media that cannot be managed with prophylaxis
- •Any contraindication to arteriography
- •Any contraindication for doxorubicin administration
结局指标
主要结局
Adverse Events
时间窗: 2- years
Progress-free-survival (PFS)
时间窗: 2-years
次要结局
- Overall Survival(2-years)
- Objective Response Rates(6-months)
研究者
Hong Shan
Professor
Fifth Affiliated Hospital, Sun Yat-Sen University
研究点 (6)
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