NL-OMON44964已完成2 期
Phase II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating unresectable liver metastases of uveal melanoma - CS-PHP-melfalan Uveal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
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
- •Informed consent
- •Liver metastases of histologically confirmed primary uveal melanoma
- •When resection of primary tumor, this has to be > 1 month before PHP and having fully recovered from surgery
- •Unresectable metastases metastases confined to the liver based on CT-Thorax/abdomen and PET imaging
- •Metastases measurable on CT-scan
- •Life expectancy > 4 months
- •APTT < 32.5 sec (<= 1.5 times ULN if considered due to tumor)
- •PT < 13.7 sec (<= 1.5 times ULN if considered due to tumor)
排除标准
- •Biological age <18 and >75 years
- •WHO performance status >= 2 (Appendix A)
- •< 40% healthy liver tissue
- •Aberrant vascular anatomy or vascular abnormalities (e.g. severe atherosclerosis, vascular dissections), which impede PHP
- •Severe comorbidity (e.g. cardiovascular and pulmonary disease precluding general anaesthesia, diabetes with nephropathy, active infections, other liver disease)
- •Incompetent / Mentally disabled
- •Pregnancy, inadequate contraception
- •Intracranial lesions with a propensity to bleed (on Brain CT or MRI)
- •LDH (> 2 times ULN)
研究者
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