Clinical trial

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

Name
BPL-Nimo-SCCHN-RWS-1
Description
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 .
Trial arms
Trial start
2021-10-08
Estimated PCD
2023-03-15
Trial end
2023-04-30
Status
Completed
Treatment
nimotuzumab
Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group).
Arms:
study group
Other names:
chemoradiotherapy
Size
1931
Primary endpoint
3-year overall survival (OS) rate
Up to 3 years
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1931, 'type': 'ACTUAL'}}
Updated at
2023-07-27

1 organization

1 product

1 abstract

1 indication

Abstract
Nimotuzumab in combination with intensity modulated radiotherapy improve survival in locally advanced head and neck squamous cell carcinoma (LA-HNSCC): A multicenter-based real-world study.
Org: Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Sichuan Cancer hospital institute, Chengdu, China, Department of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People’s Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China, PLA General Hospital, Beijing, China, Sun Yat-sen University Cancer Center, Guangzhou, China,