RPCEC00000181已完成4 期
Safety assessment of CIMAvax-EGF in patients with lung tumors of advanced non-small cell treated in Primary Health Care
Center of Molecular Immunology (CIM)0 个研究点目标入组 1,081 人开始时间: 2014年8月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,081
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
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Diagnosis NSCLC IIIb / IV in secondary care
- •2. Either sex, and age equal or greater than 18 years.
- •3. Eligible No chemotherapy or radiation therapy or who have received the treatment oncospecific available and have no other therapeutic option.
- •4. Which have signed informed consent for research.
- •5. Criteria of clinical status ECOG 0-3.
排除标准
- •1. Patients who have previously received treatment with EGF therapeutic vaccine CIMAvax and / or Nimotuzumab (therapeutic monoclonal antibody hR3).
- •2. Patients with chronic or acute infectious diseases, inflammatory or unbalanced
- •3. Patients with decompensated diabetes.
- •4. Patients of childbearing potential not using adequate contraception accept (intrauterine devices, barrier methods, or tubal ligation, hormonal methods).
- •5. Pregnant patients or nursing.
- •6. Patients with acute allergic conditions or history of severe allergic reactions.
- •7. Patients who can not attend or receive the proposed I have difficulties in accessing the APS treatment center.
研究者
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