imotuzumab inoperable esophageal epithelial tumors, Phase IV

Phase 4

• Conditions: inoperable tumors of the esophagus; Esophageal Neoplasms; Inoperable esophageal tumors of epithelial origin, located in cervical esophagus or intra-thoracic (upper thoracic portion or half) of new diagnosis, relapse or progression.; Carcinoma; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Glandular and Epithelial

• Registration Number: RPCEC00000215
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-30
• Study Completion: 2020-02-25
• Results First Posted: 2020-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who met the diagnostic criteria.
2. Patient express written participate in the study by signing the informed voluntary consent.
3. Patient aged = 18 years.
4. Life expectancy equal to or greater than 6 months.
5. Clinical status as criteria ECOG = 2

Exclusion Criteria

1. Pregnancy, postpartum and breastfeeding
2. Patients with a second tumor concomitant with the exception of basal or squamous cell skin carcinoma in situ and neck carcinoma treated or diagnosed by CT brain metastasis, progression or uncontrolled.
3. Presence of chronic disease or uncontrolled intercurrent (including active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia and psychiatric or social diseases that may limit adherence to clinical trial requirements), or congenital or acquired immunodeficiency at the time of inclusion.
4. Known hypersensitivity to any component of the Nimotuzumab formulation.
5. Presence of allergic conditions or septic acute or severe processes.
6. The patient has received prior treatment with Nimotuzumab or other biological therapy 6 months prior to enrollment, or is receiving other investigational product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (serious) with causality relationship with the product under study (Very likely, probable or possible). Measuring time: 2 years <br>