imotuzumab safety and effectiveness in inoperable esophageal tumors of epithelial origin. Phase IV

Center of Molecular Immunology (CIM)0 个研究点开始时间: 2016年6月30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: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. Patients who met the diagnostic criteria.
•2. Patient express written participate in the study by signing the informed voluntary consent.
•3. Patient aged = 18 years.
•4. Life expectancy equal to or greater than 6 months.
•5. Clinical status as criteria ECOG = 2

•1. Pregnancy, postpartum and breastfeeding
•2. Patients with a second tumor concomitant with the exception of basal or squamous cell skin carcinoma in situ and neck carcinoma treated or diagnosed by CT brain metastasis, progression or uncontrolled.
•3. Presence of chronic disease or uncontrolled intercurrent (including active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia and psychiatric or social diseases that may limit adherence to clinical trial requirements), or congenital or acquired immunodeficiency at the time of inclusion.
•4. Known hypersensitivity to any component of the Nimotuzumab formulation.
•5. Presence of allergic conditions or septic acute or severe processes.
•6. The patient has received prior treatment with Nimotuzumab or other biological therapy 6 months prior to enrollment, or is receiving other investigational product.

发起方

Center of Molecular Immunology (CIM)