RPCEC00000142已完成1 期
Biodistribution and pharmacokinetics, safety and therapeutic effect of the CIGB-300 application in the epidermoid carcinoma of the uterine neck stage IB2-II
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点开始时间: 2013年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
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: Uncontrolled. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- Female
入选标准
- •1. Clinical, imagenological and histological diagnosis of stage IB-II epidermoid cervical cancer. 2. Age between 18-75 years, both included. 3. Written informed consent by the patient. 4. Clinical laboratory parameters within normal limits. 5. General health index from 0 to 2, according to WHO classification. 6. Life expectation of more than 1 year.
排除标准
- •1. To have received surgical, ablative or immunomodulatory treatment during the 30 days before inclusion. 2. Body Mass Index lower than 19 or greater than 30. 3. Pregnancy or nursing. 4. Other decompensate chronic disease (arterial hypertension, diabetes mellitus, chronic renal disease, cardiac insufficiency,hyperthyroidism, malignant neoplasia, epilepsy, severe mental depression). 5. Previous diagnosis of dysfunction of coagulation and other decompensate chronic hematopahies (hemophilia, leukemia, among other). 6. Clinical laboratory values outside normal ranges before the treatment. 7. Referred Immunosuppressor disease and current ingestion of immunosuppressor / immunomodulating drugs (including steroids) 30 days previous the study. 8. Autoimmune disorders (Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Type 1 Diabetes Mellitus, etc.) and severe allergic antecedents such as Urticaria, Dermatitis, Bronchitis and persistent Bronchial Asthma. 9. Febrile illness (temperature >37.8°C) at time or 24 hours before administration of the product or acute infectious disease suspected by clinical examination. 10. Diseases that compromise the state of the patient's conscience or their possibility to give informed consent or collaborate in the trial. 11. Tumoral extensive necrosis that prevent the application of the product as indicate the protocol. 12. To be included in another clinical trial or to have been included in a previous trial the last 8 weeks prior to inclusion.
研究者
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