NL-OMON41379招募中2 期
Fase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases - CS-PHP-Melphalan
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
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
- •- Liver metastases of histologically confirmed primary colorectal adenocarcinoma
- •- Resection of primary tumor > 1 month before IHP
- •- Irresectable metastases confined to the liver based on CT-Thorax/abdomen and PET imaging
- •- Metastases measurable on CT-scan
- •- Informed consent
- •- Life expectancy > 4 months
- •- Leukocytes * 3.0 X 10^9/L
- •- Thrombocytes * 100 X 10^9/L
- •- Creatinine clearance * 40 ml/min
- •- Bilirubin <17 µmol/L
- •- APTT < 32.5 sec
- •- PT < 13.7 sec
排除标准
- •- Biological age <18 and >75 years
- •- WHO performance status * 2 (Appendix A)
- •- < 40% healthy liver tissue
- •- Aberrant vascular anatomy, which impedes IHP (e.g. aberrant right or left hepatic artery, severe atherosclerosis, vascular dissections)
- •- Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections, other liver disease)
- •- Incompetent / Mentally disabled
- •- Pregnancy, inadequate anticonception
研究者
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