EUCTR2008-001560-37-DE进行中（未招募）1 期
Sequentielle Kombination einer Chemotherapie mit Gemcitabine/Oxaliplatin und photodynamischen Therapie beim fortgeschrittenen Gallengangskarzinom - GemOx-PDT
Medizinische Fakultät der TU-München, vertreten durch den Dekan0 个研究点目标入组 24 人开始时间: 2008年5月14日最近更新:
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
- 24
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
- 性别
- All
入选标准
- •before study beginn:
- •- histological and/or cytological proven cholangiocarcinoma or cholangiocarcinoma specific findings in at least two diagnostic approaches (ERCP, PTCD, cholangioscopy, computed tomography, magnetic resonance tomography)
- •- biliary sticture with sufficient biliary drainage.
- •- non-resectable/non-operabel
- •- Karnofsky-Index > 60%
- •- age > 18 years
- •- informed conset
- •before chemotherapy:
- •- bilirubin < 5 mg/dl
- •- GOT/GPT < 5 upper limit of norm
- •- kreatinin < 2 upper limit of norm
- •- thrombozytes > 100 G/l
- •- neutrophile granulocytes > 2 G/l
- •- Hemoglobin > 9 g/dl
- •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
- •- self expanding metal stent
- •- photodynamic therapy in patients history
- •- chemotherapy in patients history
- •- second malignant tumor
- •- porhyria
- •- pregnant and nursing woman
- •- child bearing potential
- •- peripheral sensory neuropathy
- •- oxaliplatin hypersensitivity
- •- gemcitabine hypersensitivity
研究者
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