RPCEC00000113已完成1 期
Open Clinical Trial, uncontrolled, dose escalation, the application of IGBC-300 in microinvasive cancer, carcinoma in situ and severe dysplasia of the cervix.
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.0 个研究点开始时间: 2011年5月17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
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- Female
入选标准
- •1. Age between 18-65 years inclusive. 2. Histological diagnosis of high grade lesions and microinvasive squamous cell carcinoma of the cervix (stage 1A1 FIGO classification). 3. Presence of residual lesion after the initial punch with diameter = 3 mm, measured by videocolposcopy and corresponding with major changes or invasive stage in the nomenclature of the International Federation of Cervical Pathology and Colposcopy (Barcelona, 2002). 4. Written informed consent and signed by the patient.
排除标准
- •1.Patients meeting any one of the following were excluded from entering the study: Chemotherapy or surgical, ablative, radiant, or immunomodulator treatment, up to 3 months before inclusion. 2.Psychiatric dysfunction. 3.Pregnancy and breast-feeding. 4.Chronic diseases such as asthma, diabetes, epilepsy, autoimmune disease, hypertension, anaemia, acute bacterial or mycotic systemic or genital tract infections, renal, hepatic and cardiovascular disorders. 5.Abnormal laboratory tests. 6.Participation in another therapeutic study within 8 weeks prior to inclusion.
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