EUCTR2018-002163-26-FR进行中（未招募）1 期
Pilot study on doxorubicin kinetic distribution during arterial chemoembolization - CINEDOXO
Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 1 人开始时间: 2018年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- man and womanof 18 years old or older
- •- Subject affiliated to social security
- •- Subject able to understand study scope and rick and give signed informed consent
- •- histological, cytological or radiological confirmed diagnosis of Hepatocellular carcinoma:
- •?stade A (patient with transplant pending) and Class B according to BCLC Classification
- •?Sated A and Baccording to Child-Pugh classification
- •- chemoembolization indicated for unresecable hepatocellular carcinoma
- •- biological parmaters allowing chemoembolization procedure (platelet count, bilirubin, INR = 1,5, SGPT/SGOT<5N, albumin>2,5g/dl)
- •- ECOG performance status = 2
- •- effective contracpetion during all study
- •- negative prenancy test for woman child-bearing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •- Any contra-indication for the procedure of transarterial Chemoembolization, angiography, endomicroscopie, and hepatic biopsy ponction
- •- blood coagulation parameters abnormalities (TP < 50% and/or platelet <50000 /mm3 and/or ratio TCA <1,5) in spite of hemostatic measure correction
- •- Any contra-indication for fluorescein, Adriblastin®, Lipiodol®, Visipaque® , Gelita spon®, Avitène
- •- hyperthyroidism proved undiagnosed
- •- ilirubine totale > 40 µmol/L
- •-Créatinin > 2mg/dl
- •-GFR < 30ml/min/m2
- •-Neutrophiles < 1500/mm3 ou Plaquettes < 50000/µl
- •-Hémoglobin < 9g/dl
- •-white cells < 2500/mm3
- •- full or flux invesion of portal vein thrombosis
- •- extrahepatic metastasis
- •- transplant list inscription
- •- exophytic or sub capsilaire tumor, with no percutaneous access accross healthy liver with coaxial needle
- •- exclusion period
- •- subject unable to understand study information
- •- Psychiatric disorders and adults under guardianship
- •- Pregnancy or breastfeeding
- •- Patients under judicial protection
研究者
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