A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN (Redbull-1)

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

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 .

Study Overview

• Status: Completed
• Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 1931

Contacts and Locations

• Study Contact: Name: Lihua He; Phone Number: 010-51571020-8753; Email: lucy_he@biotechplc.com
• Study Contact Backup: Name: Yucheng Wang; Phone Number: 18810467314; Email: wangyucheng@biotechplc.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100853
      • The General Hospital of the People's Liberation Army
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen University Cancer Centre
  • Shannxi
    • Xi'an, Shannxi, China, 710061
      • First Affiliated Hospital of Xi 'an Jiaotong University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who were more than 18 years old, and were proved to be LASCCHN were included in this study. Patients in the control group receive chemoradiotherapy, while patients in the study group received nimotuzumab on the basis of chemoradiotherapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; Patients of study group were all treated with chemoradiotherapy plus nimotuzumab.	Drug: nimotuzumab; Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group).; Other Names: chemoradiotherapy
control group; Patients of control group were only treated with chemoradiotherapy, and were collected at least 3 times as many patients as the study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival (OS) rate	3-year overall survival (OS) rate	Up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biotech Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Jinyi Lang, Sichuan Cancer Hospital and Research Institute; Study Chair: Chenping Zhang, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medcine; Study Chair: Junlin Yi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: BPL-Nimo-SCCHN-RWS-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No