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A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN | Clinical Trials | Clareo Health

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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

NCT04949503•Biotech Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, China

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shannxi, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

October 8, 2021

Primary Completion Date

March 15, 2023

Completion Date

April 30, 2023

Last Updated

July 27, 2023

Enrollment

1,931

ACTUAL participants

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

nimotuzumab

DRUG

Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

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Locally Advanced Head and Neck Squamous Cell Carcinoma

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Locally Advanced Head and Neck Squamous Cell Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck

Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin

Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer