imotuzumab in the treatment of pre-malignant lesions of the esophagus. Exploratory Study

Center of Molecular Immunology (CIM)0 个研究点目标入组 36 人开始时间: 2024年6月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•1. Patients with premalignant lesions of Barrett's esophagus, confirmed by biopsy, without dysplasia, of any sex.
•2. Patients who sign the informed consent to participate in the study.
•3. People over 19 years of age without age limit.
•4. Chronic diseases compensated.
•5. Clinical laboratory parameters and blood hemochemistry up to 1.5 times above or below the normal values established in the CNCMA laboratories.
•6. Patients of childbearing age with proven contraceptive methods. Negative pregnancy test prior to inclusion.

•1. The patient does not agree to sign the informed consent or withdraws it.
•2. Pregnant, postpartum and breastfeeding women.
•3. EB patients with dysplasia of any grade
•4. Cholecystectomized patients.
•5. Patients with any confirmed neoplasia.
•6. Patients with very low grade dysplasias or without dysplasias.
•7. Allergic to any component of the formulation.
•8. Receiving another investigational product.
•9. Patient with a very high degree of severe or very severe dysplasia.
•10. Laboratory parameters greater than 1.5 times above or below normal parameters.

发起方

Center of Molecular Immunology (CIM)