Clinical trial NCT04949503: A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 1931
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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 .

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 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.

Primary outcomes:
measure: 3-year overall survival (OS) rate
timeFrame: Up to 3 years
Secondary outcomes:
measure: 3-year progression-free survival (PFS) rate
timeFrame: Up to 3 years
measure: 3-year Local-regional control (LRC) rate
timeFrame: Up to 3 years
measure: objective response rate (ORR)
timeFrame: Up to 12 months
measure: disease control rate (DCR)
timeFrame: Up to 12 months
measure: Safety as measured by number and grade of adverse events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Centre
state: Guangdong
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi 'an Jiaotong University
state: Shannxi
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Jinyi Lang
role: STUDY_CHAIR
affiliation: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medcine
name: Chenping Zhang
role: STUDY_CHAIR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Junlin Yi
role: STUDY_CHAIR
References: