Esofagus Pre malignan lesion
Conditions
Interventions
Nimotuzumab group (Experimental): Nimotuzumab plus Omeprazole. The Nimotuzumab be administered intravenously (antecubital vein), equivalent to 200 mg diluted in 250 mL of 0.9% saline solution (total v
Sponsors
Center of Molecular Immunology (CIM)
Not aplplicable
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with premalignant lesions of Barrett's esophagus, confirmed by biopsy, without dysplasia, of any sex. 2. Patients who sign the informed consent to participate in the study. 3. People over 19 years of age without age limit. 4. Chronic diseases compensated. 5. Clinical laboratory parameters and blood hemochemistry up to 1.5 times above or below the normal values established in the CNCMA laboratories. 6. Patients of childbearing age with proven contraceptive methods. Negative pregnancy test prior to inclusion.
Exclusion criteria
Exclusion criteria: 1. The patient does not agree to sign the informed consent or withdraws it. 2. Pregnant, postpartum and breastfeeding women. 3. EB patients with dysplasia of any grade 4. Cholecystectomized patients. 5. Patients with any confirmed neoplasia. 6. Patients with very low grade dysplasias or without dysplasias. 7. Allergic to any component of the formulation. 8. Receiving another investigational product. 9. Patient with a very high degree of severe or very severe dysplasia. 10. Laboratory parameters greater than 1.5 times above or below normal parameters.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse Events-AEs (Type of AE (description of the AE); organ system (system to which it belongs according to the CTCAE v5.0 classification); Duration (Time from the start until finish the AE); Intensity ( Mild, moderate, Severe according to Cecmed regulation 45/2007); Outcome (Reversible effect, Irreversible effect, Loss of follow-up, Death (No change, Temporary interruption, Definitive interruption) and Causal relationship (Very probable/ certain, Probable, Possible, Improbable, Not related, Not evaluable/not classifiable according to Cecmed regulation 45/2007)). Measurement time: over 12 months. 2. Correlation of the response with prognostic factors such as EGFr expression, NLR, PLR inflammatory indices (values of each prognostic factor). Measurement time: At baseline, 12 weeks, 6 months and 12 months 3. Clinical Laboratory (Values of: Hemoglobin, Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrocyte sedimentation rate, Amino-Aspartate Transferase, Glutamic Pyruvic Transferase, GGT, Cholesterol). Measurement time: At baseline, 12 weeks, 6 months and 12 months | — |
Primary
| Measure | Time frame |
|---|---|
| Saffety: 1. Serious Adverse Events (SAE) with a causal relationship (Patients proportion with SAE according to the CTCAE v5.0 classification that have a causal relationship Very probable/ certain, Probable, Possible according to Cecmed regulation 45/2007). Measurement time: over 12 months Effect: 1. Reduction of the premalignant lesion of Barrett's Esophagus (Proportion of patients who reduce the lesion with respect to the baseline time using endoscopic images). Measurement time: at baseline, 12 weeks, 6 months and 12 months 2. Duration of the response (Time in which the response is maintained). Measurement time: 12 weeks, 6 months and 12 months | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos Suzarte
Center of Molecular Immunology (CIM)
Outcome results
None listed