Combined immunotherapy with the vaccine preparation NGcGM3/VSSP and the monoclonal antibody nimotuzumab, in patients with advanced non-small cell lung cancer (NSCLC)

Center of Molecular Immunology (CIM)0 个研究点目标入组 30 人开始时间: 2018年4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: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment

•1. Patients with confirmed diagnosis of NSCLC
•2. Patients who consent to participate in the study by signing the informed consent model.
•3. Patients older than 18 years.
•4.Clinical and radiological documentation the evaluation of the response to the oncoespecific treatment of 1st line
•5. Partial or stable response (RECIST), at the end of the first-line onco-specific treatment.6.Patients with + expression of EGF-R and / or NGcGM3
•7.Patients with ECOG scale of Performance Status = 2.
•8.Life expectancy at least 6 month
•9. Time from the end of first-line oncospecific therapy to inclusion, no longer than 2 months
•10. Patients with normal functioning of organs and bone marrow defined by laboratory parameters - Hemoglobin >9 g/L, - White blood cell (WBC) count > 3000/ µL, - Neutrophils = 1.5 x 109/L , - Platelet count = 100,000 per µL, - Total bilirubin: in normal labs values, - AST and ALT = 2.5 x upper limit of normal (ULN), - Serum creatinine in normal labs values, - Glycemia: in normal labs values

•1.Patients with fertile age.
•2. Pregnancy, lactation or puerperium.
•3. Patients with history of severe allergy disease.
•4. Patients who have been treated with NGcGm3/VSSP, nimotuzumab or some other EGF-R blocker.
•5. Patients with descompensated chronic diseases.
•6. patients with previous demyelinating and inflammatory diseases
•7. Patients with previous malignancies, except carcinoma in situ of cervix or skin cancer (non-melanoma), correctly treated
•8. Patients with acute or chronic infectious diseases
•9. Patients with brain metastases.

发起方

Center of Molecular Immunology (CIM)