NCT02870010已完成1 期
Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Tolerance: toxicities will be defined according to the scale: National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTC AE v3.0) to determine the limiting dose
研究概览
简要总结
Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC)
- classical chemoembolization consists in injecting an emulsion of an anticancer agent in Lipiodol® via the hepatic artery
- doxorubicin, an anthracycline, is the most frequently used drug in lipiodol chemoembolization (LCE)
- however, less than half of HCC respond favourably to classical lipiodol chemoembolization (LCE) with doxorubicin/Lipiodol®
In this trial, we propose to introduce in clinical practice a strategy based on idarubicin to achieve a more effective antitumor effect for the following reasons, recently pointed out by our team:
- idarubicin is an anthracycline that penetrates tumour cells more quickly and is more cytotoxic than doxorubicin on hepatocellular carcinoma cell lines
- idarubicin is injected in a solution of embolization microspheres of a diameter of (300-500µm), which all the progressive and controlled release of the anticancer drug, whereas the doxorubicin/Lipiodol® emulsion is unstable
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma(HCC) proven by cytology or histology or diagnosis according to the 2005 criteria of the American Association for the Study of Liver Diseases, (AASLD), which requires the presence of histological or unequivocal cirhosis and according to the size of nodules:
- •nodule < 1 cm: increase in the size according to US scan every 3-4 months
- •nodule between 1 and 2 cm: 2 concordant imaging techniques: CT-scan, MRI, contrast-enhanced US (CEUS); diagnosis of Hepatocellular carcinoma (HCC) in the presence of typical images (hypervascularized arterial + wash-out phase) with 2 imaging methods; in other cases, biopsy.
- •nodule > 2 cm: CT-scan or MRI or CEUS (only 1 technique); diagnosis of Hepatocellular carcinoma (HCC) in the presence of hypervascularization associated with either a wash-out image or alphafoetoprotein> 200 µg/L; in other cases, biopsy.
- •A maximum of 3 nodules (Single-lobe disease - no limit to the number of nodules, in bilobar disease - a maximum of 3 nodules) distributed throughout the liver and detected by liver MRI with the injection of Gadolinium chelate, dating back less than 1 month. In cases of a contra-indication for MRI (pacemaker, metallic intra-ocular foreign body, certains cardiac valves et certains intra-cranial clips), a CT-scan with and without iodine-based contrast).
- •cases of cirrhosis: Child-Pugh stage A or B 7 without ascites, or icterus
- •WHO perfomance status 0, 1
- •Platelets > 50 000/mm3, Polynuclear neutrophils > 1000/mm3
- •Creatininemia < 150 µmol/l
- •Absence of heart failure (isotopic or US LVEF > 50%)
- •Age >18 years
- •Written informed consent
排除标准
- •Patients able to undergo surgical resection or liver transplantation or local treatment with radio-frequency ablation
- •Extra-hepatic metastases (lungs, bones, peritoneum...)
- •Digestive haemorrhage dating back less than one month
- •Patients on anticoagulants
- •Portal thrombosis occurring in more than one segmental branch or hepatofugal flow on the Doppler
- •Pregnant women
- •Uncontrolled infection
- •Hypersensitivity to anthracyclines
- •Hypersensitivity to iodine contrast agents
- •Patients under guardianship
结局指标
主要结局
Tolerance: toxicities will be defined according to the scale: National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTC AE v3.0) to determine the limiting dose
时间窗: total duration of participation for a patient: 2 months
Patients will be hospitalized for 3 days starting from the date of the chemoembolization and will then be followed regularly for 2 months from the date of the chemoembolization (clinical, biological and radiological surveillance).
次要结局
未报告次要终点
研究者
研究点 (2)
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