EUCTR2005-000163-25-GB进行中（未招募）1 期
Proteomics and Pharmacokinetics of Adriamycin Following Different Techniques for Chemoembolisation of Hepatocellular Carcinoma (PPATCH) Trial - PPATCH
Research and Enterprise, University of Birmingham0 个研究点目标入组 20 人开始时间: 2005年5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
- 20
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
入选标准
- •Fulfil criteria for diagnosis of HCC:
- •At least one of the following need to be met for diagnosis
- •I.Liver mass with histological confirmation of biopsied sample
- •II.Liver mass with AFP>500
- •III. Liver mass with evidence of chronic Hepatitis C with or with out cirrhosis
- •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
- •1.Extensive disease
- •a.Multi-focal disease of greater than 4 lesions in either lobe
- •b.Metastatic disease
- •2.Renal failure: GFR<60
- •3.Liver Function: No history of Encephalopathy, No ascites not easily medically controlled, Albumin>30, Bilirubin<50, If INR>1.2 administer 10mg vitamin K needs to be <1.5 to proceed
- •4.FBC: WCC<3.0, Neutophils<1.5, platelets<60
- •5.Performance status >2
- •6.Presence of vascular invasion-(including segmental portal obstruction)
- •7.Contraindication to Doxorubicin:
- •a.Ejection fraction<50%
- •b.Hypersensitivity to hydroxybenzoates
- •c.Buccal ulceration
- •8.Portosystemic shunt i.e. for oesophageal varicies,
- •9.GI bleed
- •10.Severe artheromatosis
- •11.Previous biliary surgery
研究者
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