Immunotherapy with NGcGM3/VSSP and nimotuzumab in metastatic triple negative breast cancer patients. Phase I/II

Center of Molecular Immunology (CIM)0 个研究点目标入组 45 人开始时间: 2016年10月12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: Uncontrolled. Assignment: Parallel. Purpose: Treatment

•1.Female patients with metastatic triple negative breast cancer.
•2.Patients who are candidates for treatment with first-line chemotherapy for metastatic disease.
•3.Patients with paraffin-embedded samples for evaluation of the expression of NGcGM3 and EGFR.
•4.Patients older than 18 years.
•5.Patients who consent to participate in the study by signing the informed consent model.
•6.Patients with ECOG scale of Performance Status = 2.
•7.Patients with normal functioning of organs and bone marrow defined by laboratory parameters.

•1.Patients who have been treated with NGcGm3 / VSSP or Nimotuzumab within 6 months prior to inclusion.
•2.Patients who have been included in another clinical trial within 6 months prior to inclusion.
•3.Patients with inflammatory carcinoma of the breast.
•4.Patients who are pregnant or breastfeeding.
•5.Patients with brain metastases.
•6.Patients with acute or chronic infectious diseases.
•7.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine or mAb.
•8.Patients with autoimmune diseases.
•9.Patients with descompensated chronic diseases.

发起方

Center of Molecular Immunology (CIM)