RPCEC00000219已完成1 期
Phase I clinical trial of the HER-1 vaccine in patients with prostate tumors of epithelial origin. - EC FI HER-1 CPRC
Center of Molecular Immunology0 个研究点目标入组 25 人开始时间: 2016年11月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- 分配方式
- Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 40 years 至 one（—）
- 性别
- Male
入选标准
- •1. Patients who meet the diagnostic criteria.
- •2. Patients with greater than or equal to 40 years age.
- •3. Patients who have signed informed consent.
- •4. Patients with overall as less than 2 ECOG.
- •5. Patients with longer life expectancy of 6 months.
- •6. Patients with functioning of organs and bone marrow, defined by the following parameters:
- •- Hemoglobin greater than or equal to 90 g / l
- •- White blood cell count, greater than or equal to 3.0 x 109 leucocytes / L
- •- Absolute Neutrophil Count, greater than or equal to 1.5 x Neutrophil 109 / L
- •- Platelets greater than or equal to 100 x 109 platelets / L
- •- Bilirubin values within normal limits of the institution. (0 to 17 micromol / L).
- •- TGO/TGP less than or equal to 2.5 times the upper limit of the normal range in the institution.
- •- Creatinine values within normal limits of the institution. (35-135 micromol / L)
排除标准
- •1.Patients receiving other onco-specific investigational product.
- •2.Patients with uncontrolled intercurrent illness including: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, liver damage and psychiatric illness that may limit adherence to clinical trial requirements.
- •3. Patients with brain metastases.
- •4. Patients with compromised immune systems, including current disease or history of eczema, atopic dermatitis, autoimmune disease (autoimmune neutropenia, thrombocytopenia, hemolytic anemia, HIV, lupus erythematosus, Sjogen syndrome, scleroderma, myasthenia gravis Goodpasture syndrome, Addison's disease, Hashimoto's thyroiditis, Graves' disease).
- •5. Allergic patient to any component of the formulation.
研究者
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