A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Biotech Pharmaceutical Co., Ltd.5 sites in 1 country1,931 target enrollmentOctober 8, 2021

ConditionsLocally Advanced Head and Neck Squamous Cell Carcinoma

Interventionsnimotuzumab

Drugsnimotuzumab

Overview

Phase: Not Applicable
Intervention: nimotuzumab
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor: Biotech Pharmaceutical Co., Ltd.
Enrollment: 1931
Locations: 5
Primary Endpoint: 3-year overall survival (OS) rate
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab .

Detailed Description

This study is a retrospective real-world study. The diagnosis and treatment of patients, disease management, and information collection are completely dependent on the daily medical practice. In this study, we plan to select 5 to 8 hospitals nationwide to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018. Patients included in the study will be followed up for survival. The main endpoint is 3-year overall survival (OS) rate; the secondary endpoint are 3-year progression-free survival (PFS) rate, 3-year Local-regional control (LRC) rate, objective response rate (ORR), disease control rate (DCR) and safety.

Registry

clinicaltrials.gov

Start Date

October 8, 2021

End Date

April 30, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biotech Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old, no gender limitation;
•Histopathologically or cytologically proved to be phase III-IVb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma).
•Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018;
•Patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. And patients in the control group were collected 3 times as many cases as the study group in each center. If the number of patients in the control group were less than 3 times of the study group, all cases were collected.

Exclusion Criteria

•Complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
•Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab;
•Lack of critical evaluation information.