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

Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial

— Redbull-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949503
• Other study ID #: BPL-Nimo-SCCHN-RWS-1
• Status: Completed
• Start date: October 8, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2023
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1931
• Est. completion date: April 30, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• nimotuzumab
Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group).

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	The General Hospital of the People's Liberation Army	Beijing	Beijing
China	Sun Yat-sen University Cancer Centre	Guangzhou	Guangdong
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year overall survival (OS) rate	3-year overall survival (OS) rate	Up to 3 years
Secondary	3-year progression-free survival (PFS) rate	3-year progression-free survival (PFS) rate	Up to 3 years
Secondary	3-year Local-regional control (LRC) rate	3-year Local-regional control (LRC) rate	Up to 3 years
Secondary	objective response rate (ORR)	objective response rate (ORR)=CR+PR	Up to 12 months
Secondary	disease control rate (DCR)	disease control rate (DCR)	Up to 12 months
Secondary	Safety as measured by number and grade of adverse events	Classification, frequency, and severity of drug-related adverse events	Up to 3 years