DRKS00007161招募中不适用
Irresectable intrahepatic cholangiocellular carcinoma:Evaluation of the Efficacy of multimodal treatment by interstitial HDR-Brachytherapy combined with Gemcitabine/Cisplatin Chemotherapy - CHOICE II
niversitätsklinikum Magdeburg0 个研究点目标入组 50 人开始时间: 2016年8月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 85 Years(—)
- 性别
- All
入选标准
- •histologically confirmed cholangiocellular carcinoma
- •intrahepatic localization of a massforming CCC
- •whole tumor bound of the liver not > 50%
- •at least 1 lesion is accessible to an interventional therapy
- •consent and ability to all study specific actions voluntary, informed and personally written consent
- •Patient Age not under 18 and not over 85 years
- •suitable cardiac, renal and haematological parameters
排除标准
- •pregnant or breast-feeding women respectively possible pregnancy
- •uncontrolled ascites
- •other tumor diseases within the last 5 years (expect carcinoma in situ of the skin or zervix)
- •uncooperative/noncompliant
- •already participant of this study
- •participation on another therapy study
- •contraindication for Primovist-MRI or contrast-CT
- •moderate or graved renal failure (GFR < 60 ml/min) appropriate to laboratory values 1 week before Primovist-MRI
- •previous Radiation of the liver
- •to clinic or investigator related patients
- •acute or risk of acute severe bleeding (WHO grade 3-4)
- •upper gastrointestinal bleeding in the last 3 month
- •thrombembolic events including TIA in the last 6 month
- •uncontrolled hypertonus
- •life expactancy under 16 weeks
- •state by orgn transplantation
- •congenital immune defects
- •immunsuppressive therapie in case of autoimmune disease or chronic inflammatory disease
研究者
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