EUCTR2017-004859-22-FR进行中（未招募）1 期
Treatment of hepatocellular carcinoma on child cirrhosis A/B7 by intra-arterial injection of a Lipiodol and Idarubicin emulsion : a multicentric single-arm phase II study - LIDA-BII
niversity Hospital of Monptellier0 个研究点目标入组 53 人开始时间: 2018年4月27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
- 53
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
- •Histologically proven hepatocellular carcinoma (or according to EASL criteria)
- •Child-Pugh A or B7 cirrhosis
- •Tumor not accessible to surgical resection, percutaneous ablation or radiofrequency
- •WHO 0 or 1
- •BCLC A / B or C if WHO = 1
- •Targets measurable according to mRECIST criteria v1.1
- •No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
- •Age = 18 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Advanced tumor disease
- •Diffuse hepatocellular carcinoma with liver invasion> 50%
- •Past cancers history excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ adequately treated with curative intent
- •Advanced liver disease (Child B8, B9 and C)
- •Contraindication to performing a liver MRI
- •Contraindication to the injection of gadolinium-based contrast media
- •Contraindication to Idarubicin
- •Contraindication to Lipiodol
- •Vascular anatomy makes it impossible to perform intra-arterial liver treatments
- •Ligation or sizing of gastroesophageal varices for less than a month.
- •Pregnancy (determination of positive ßHCG) or breastfeeding according to article L1121-5 of the CSP.
研究者
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