NL-OMON30309尚未招募不适用
Phase I/II study of oxaliplatin combined with melphalan in isolated hepatic perfusion for the treatment of liver metastases. - Oxaliplatin combined with melphalan in IHP.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Livermetastases of histologically confirmed colorectal adenocarcinoma and for the phase I also livermetastases from solid tumors other than colorectal carcinoma.
- •- Resection of primary tumor > 1 month prior to IHP
- •- Irresectabel metastes confined to the liver.
- •- Measurable metastases on CT-scan
- •- Informed consent
- •- Life expectancy > 4 months
- •- Leukocytes >= 3.0 X 109/L
- •- Thrombocytes >= 100 X 109/L
- •- Clearance >= 40 ml/min
- •- Bilirubin <17 µmol/L
- •- APTT < 32.5 sec
- •- PT < 13.7 sec
排除标准
- •- Biological age <18 years >65 years
- •- WHO performance status larger or equal to 2
- •- < 40% viabel liver tissue
- •- Vascular anatomy which inhibits the procedure (ie aberrant right or left hepatic artery, severe atherosclerosis, vascular dissections)
- •- Simultaneous severe medical problem (ie severe heart/vascular disease, diabetes with nefropathy, active infection and other liver disease)
- •- Mental retardation
- •- Pregnancy or inadequate anticonception
研究者
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