RPCEC00000287尚未招募1 期
Phase I-II study of dose escalation and cohort expansion with VSSP in patients with metastatic renal carcinoma - VSSPMRCC
Center of Molecular Immunology (CIM)0 个研究点目标入组 70 人开始时间: 2018年8月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
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 trial. Masking: Open. Control group: Uncontrolled. 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 that meet the diagnostic criteria (CRM or relapse, operated or not).
- •2. Patients who give their informed consent to participate in writing.
- •3. Patients of any sex with age over 18 years.
- •4. Patients with general condition = 2 (according to ECOG).
- •5. Patients with life expectancy of at least 6 months.
- •6. Patients who have adequate functioning of organs and bone marrow.
排除标准
- •1. Patients of childbearing age who are not using an adequate method of contraception prior to their inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In case of male sex (vasectomy, use of condoms).
- •2. Pregnant or lactating patients.
- •3. Patients with acute allergic states or history of severe allergic reactions.
- •4. Patients with decompensated acute or chronic lung diseases that may interfere with the follow-up of the underlying disease.
- •5. Patients with a previous history of demyelinating or inflammatory diseases of the Central Nervous System (CNS) or Peripheral (SNP).
- •6. Patients with uncontrolled intercurrent illnesses that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus and psychiatric illnesses that imply the incompetence of the subject.
- •7. Patients with cerebral metastasis.
- •8. Patients who are receiving another product under investigation.
- •9. Patients with known hypersensitivity to any component of the formulation.
- •10. Patients with positive serology known to HIV, hepatitis B or C.
研究者
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