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

NCT04949503 | Completed DMC

• 1 other identifier: BPL-Nimo-SCCHN-RWS-1
• Study Type: observational
• Target: 1,931
• Locations: 1 country
• Sites: 5

Brief 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 .

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival (OS) rate

  3-year overall survival (OS) rate

  Up to 3 years

Secondary Outcomes (5)

• 3-year progression-free survival (PFS) rate

  Up to 3 years

• 3-year Local-regional control (LRC) rate

  Up to 3 years

• objective response rate (ORR)

  Up to 12 months

• disease control rate (DCR)

  Up to 12 months

• Safety as measured by number and grade of adverse events

  Up to 3 years

Study Arms (2)

study group

Patients of study group were all treated with chemoradiotherapy plus nimotuzumab.

Drug: nimotuzumab

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.

Interventions

nimotuzumab DRUG

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

Also known as: chemoradiotherapy

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, 100853, China

Location

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, 510000, China

Location

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shannxi, 710061, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

nimotuzumab; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: October 8, 2021
• Primary Completion: March 15, 2023
• Study Completion: April 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-06

Locations

CN (5)