Nimotuzumab in Esophagus premalignant lesions

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Nimotuzumab in the treatment of pre-malignant lesions of the esophagus. Exploratory Study

Secondary indentifying numbers:

FL-EC-0030

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM); Cuban Ministry of Public Health (Minsap)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Felipe

Midle name:

Nery

Last name:

Pinnol Jimenez

Medical Specialty :

Second Degree specialist of Gastroenterology

Affiliation:

National Center for Minimally Invasive Surgery (CNCMA)

Postal address:

Calle Parraga No. 215 e/ Vista Alegre y San Mariano, Municipio 10 de Octubre

City:

Havana

Country:

Cuba

Zip Code:

10700

Telephone:

+53-76415275

+53-58056239

Email address:

pinolfelipe223@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

31/08/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Esofagus Pre malignan lesion

Intervention(s):

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 volume of 290 ml), in a 2-hour infusion. It will be administered 6 doses, once every fifteen days, concomitantly with Omeprazole. The Omeprazole will be administered a dose of 40 mg/day, for 12 weeks, orally, divided into two doses of 20 mg before breakfast and dinner. Omeprazole group (Control): The Omeprazole will be administered a dose of 40 mg/day, for 12 weeks, orally, divided into two doses of 20 mg before breakfast and dinner. After 12 weeks, the patient will be evaluated. If the patient responses, the scheme will repeat again.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

0

Target sample size:

36

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mayra

Last Name:

Ramos Suzarte

Specialty:

Biochemistry. PhD

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15. Atabey. Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayra

Last Name:

Ramos Suzarte

Specialty:

Biochemistry. PhD

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15. Atabey. Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Center for Minimally Invasive Surgery (CNCMA)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

01/03/2024

Postal address of Ethic Committee :

Calle Parraga No. 215 e/ Vista Alegre y San Mariano, Municipio 10 de Octubre. ZC: 10700, Havana. Cuba

Telephone:

+53-58056239

Email:

fpinol@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

23/08/2026

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000446

Date of Registration in Primary Registry:

21/06/2024

Record Verification Date:

2024/06/21

Next update date:

2025/06/21

Link to the spanish version:

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Registered Trials

Registration process

Nimotuzumab in Esophagus premalignant lesions

About the RPCEC

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