Effect of combined vaccination of CIMAvax-EGF and intravesical BCG in treatment of non-muscle invasive bladder cancer.

Center of Molecular Immunology (CIM)0 个研究点目标入组 40 人开始时间: 2020年8月11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 diagnosed with NMIBC, confirmed by RTU or partial cystectomy.
•2.Eligible patients’ are 18 years or older.
•3.Non-other cancer previously diagnosed.
•4.Capable to sign the informed consent for the investigation.
•5.Patients with an Eastern Cooperative Oncology Group (ECOG) performance status index ranging from 0 to 3.

•1.Patients who have previously received treatment with the therapeutic vaccine CIMAvax®EGF and / or Nimotuzumab (Therapeutic monoclonal antibody hR3), or any other product under investigation.
•2.Patients whose biopsy sample was not useful to define the degree of tumor infiltration or because the degree of tumor differentiation and infiltration was not reported in the pathology report.
•3.Patients of childbearing age who do not use adequate contraceptive methods (intrauterine devices, barrier methods or tubal ligation).
•4.Pregnant or lactating patients.
•5.Patients with acute allergic states or history of severe allergic reactions.
•6.Patients who present psychiatric or neurological diseases with an inability to understand or sign the informed consent.
•7.Contraindication for the use of intravesical BCG treatment.

发起方

Center of Molecular Immunology (CIM)