NCT04949503

A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,931 (actual)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	nimotuzumab	Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group).

Timeline

• Start date: 2021-10-08
• Primary completion: 2023-03-15
• Completion: 2023-04-30
• First posted: 2021-07-02
• Last updated: 2023-07-27

Locations

5 sites across 1 country: China