RPCEC00000223招募中2 期
Specific active immunotherapy with the vaccine preparation NGcGM3/VSSP in the treatment of patients with metastatic cutaneous melanoma
Center of Molecular Immunology (CIM)0 个研究点目标入组 160 人开始时间: 2016年12月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Patients who received first-line onco-specific therapy according to the treatment guidelines and who completed the different protocols between 4 and 8 weeks prior to inclusion in the trial.
- •2. Patients older than 18 years
- •3. Patients with life expectancy of 6 months or more.
- •4. Patients with functional capacity assessment less than or equal to 2, according to ECOG criteria.
- •5. Informed Consent signed.
排除标准
- •1.Patients who are pregnant or breastfeeding.
- •2.Patients with brain metastases.
- •3.Patients with acute or chronic infectious diseases.
- •4.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine .
- •5.Patients with autoimmune diseases.
- •6.Patients with descompensated chronic diseases.
研究者
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