ISRCTN32669229已完成不适用
Palliative Chemotherapy (2nd line) with Imatinib (Glivec™) in Patients with Bile Duct Cancer
niversity of Leipzig (Germany)0 个研究点目标入组 40 人开始时间: 2006年2月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Two-dimensional detectable tumors or metastasis
- •2. Aged between 18 and 75 years
- •3. General condition - World Health Organisation (WHO) <2
- •4. Live expectancy of at least three months
- •5. Informed consent
- •6. Bilirubin not to be elevated more than upper normal value (1.5 times in the presence of liver metastasis) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 1.5 times (2.5 times in the presence of liver metastasis) of the upper normal value
- •7. Creatinine <133 µmol/l (<1.5 mg/l), creatinine clearance >60 ml/min
排除标准
- •1. Pregnant and lactating women, fertile men and women without adequate contraception
- •2. Patients that have not received primary chemotherapy
- •3. Pre-operated tumor recurrence
- •4. Tumor extent >50% of the liver or >25% of the lung, abdominal mass >10 cm, Central Nervous System (CNS) metastasis
- •6. Non-measurable tumor
- •7. Known intolerance to imatinib and its preservatives
- •8. Second malignancy
- •9. Second unstable disease
- •10. Co-medication with non-approved drugs
- •11. Any other anti-cancer treatment
- •12. Co-medication with paracetamol
研究者
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