Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity assessed according NCI CTC AE v3.0
研究概览
简要总结
The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.
详细描述
Hepatocellular carcinoma (HCC) is the fifth most common malignancy and the third most common cause of cancer-related death worldwide. Most of the patients are diagnosed at intermediate-advanced stage when the sole standard treatment is transarterial chemoembolization (TACE). In the literature, survival rates in TACE studies vary widely and finally, there is no suggestion for the best chemotherapeutic agent or the optimal treatment regimen.
We hypothesise that the use of idarubicin (the most cytotoxic drug on HCC cell lines) in DC Bead would enhance the efficacy of TACE. The primary objective of the study is to determine the maximal tolerated dose of idarubicin in DC Bead for chemoembolization of non resectable non metastatic hepatocellular carcinoma.
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 cytologically or histologically proved or diagnosed according the criteria of the American Association for the Study of Liver Diseases(AASLD 2005)
- •Three nodules maximum (unilobar disease without limitation in the number of nodules; 3 maximum nodules if bilobar disease [satellite nodules <1cm not included in the total sum])
- •Child-Pugh score A or B7
- •ECOG Performance Status < 2
- •Platelet count > 50,000/µl and absolute neutrophil count (ANC) >1,000/µl
- •Serum creatinine < 150 µmol/l
- •Resting ejection fraction > 50% (echocardiography or isotopic method)
- •Age > 18 years
- •Signed written informed consent
排除标准
- •Patients eligible for surgical resection or hepatic transplantation or radiofrequency ablation
- •Extrahepatic metastases
- •Known gastrointestinal bleeding up to 30 days before study entry
- •Patients with anticoagulant treatment
- •Evidence of portal vein thrombosis
- •Pregnancy
- •Clinically serious infection
- •Known hypersensitivity to anthracyclines
- •Known hypersensitivity to contrast medium
研究组 & 干预措施
Idarubicin
Dose escalation: level0 = idarubicin 5mg, level1 = idarubicin 10mg, level2 = idarubicin 15mg, level3 = idarubicin 20mg, level4 = idarubicin 25mg
干预措施: idarubicin (Drug)
结局指标
主要结局
Dose-limiting toxicity assessed according NCI CTC AE v3.0
时间窗: Within the first month after chemoembolization
次要结局
- Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.(2 months)
- Quality of life (EORTC QLQ-C30)(2 months)
- Pharmacokinetics parameters of idarubicin and idarubicinol(Within 72 hours after chemioembolization)