EUCTR2008-005584-33-NL进行中（未招募）1 期
Dendritic cell vaccination in patients with Lynch Syndrome or colorectal cancer with MSI - DC vaccination in lynch syndrome patients
Radboud University Nijmegen Medical Centre0 个研究点目标入组 25 人开始时间: 2009年7月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- •histologically documented evidence of CRC (group I) and Lynch syndrome carrier without signs of disease (group II)
- •HLA-A2.1 phenotype is required
- •MSI high tumor
- •WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l, serum crea¬tinine <150 µmol/l, serum bilirubin <25 µmol/l
- •WHO performance status 0-1 (Karnofsky 100-70%)
- •age 18-75 years
- •expected adequacy of follow-up
- •written informed consent
- •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
- •history of malignancy in the past 5 years with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •serious active infections, HbsAg or HIV positive (test only in case of high risk or clinical suspicion)
- •autoimmune diseases or organ allografts
- •concomitant use of immunosuppressive drugs
- •known allergy to shell fish
- •pregnant or lactating women
研究者
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