RPCEC00000144已完成2 期
Open study, single center, perilesional and intralesional application of HeberPAG ® in squamous carcinomas of the skin, stage I and II
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 27 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
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 /A (No limit)（—）
- 性别
- All
入选标准
- •1. Clinical and histological diagnosis of ECC*. 2. > 18 years of age. 3. Lesions between 1.5 - 5.0 cm. 4. Invasive clinical subtype, from any location and photo type of skin. * If the patient has more than one lesion, the largest that falls within the range of inclusion (1.5 - 5.0 cm) will be treated.
排除标准
- •1. Pregnancy, postpartum or breastfeeding women. 2. Hypersensitivity to HeberPAG or other preparations used in the study. 3. Intraepithelial clinical subtypes or in situ of the ECC (Actinic keratosis, Bowen's Disease / Erythroplasia of Queirat, keratoacanthoma). 4. Uncompensated severe arterial hypertension proven by clinical examination. 5. Chronic arterial insufficiency reported by patients and verified by physical examination 6. Diabetes mellitus, Sickle-cell disease. 7. Severe hematological disorders, checked by complementary laboratory measurements (hemoglobin <10 g/l in women and 11 g/l in men). 8. Diseases with metabolic involvement (liver diseases, kidney diseases, pancreatopatías, collagenopathies) reported by the patient and verified by clinical and laboratory examinations (AST, ALT, alkaline phosphatase, bilirubin, creatinine, serum amylase). 9. Very committed general condition (cachexia, severe debilitating disease patients). 10. Patients treated with steroids, immunosuppressants, IFN alpha or gamma in the last three months. 11. Patients receiving other specific cancer treatment at the time of inclusion. 12. Other malignancies and immunological diseases reported by the patient and confirmed by clinical examination. 13. Severe psychiatric disorders or other constraints that prevent the patient's consent or hinder evaluation.
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