CIMAvax-EGF in Bladder cancer
- Conditions
- on-muscle invasive bladder cancerUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsCarcinoma in SituCarcinomaUrinary Bladder DiseasesUrologic Diseases
- Registration Number
- RPCEC00000331
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two years recurrence rate (proportion of patients with recurrence/total of patients). Measurement time: 2 years
- Secondary Outcome Measures
Name Time Method