Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGnimotuzumab
Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group).
Sponsors
Biotech Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival (OS) rate | Up to 3 years | 3-year overall survival (OS) rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year progression-free survival (PFS) rate | Up to 3 years | 3-year progression-free survival (PFS) rate |
| 3-year Local-regional control (LRC) rate | Up to 3 years | 3-year Local-regional control (LRC) rate |
| objective response rate (ORR) | Up to 12 months | objective response rate (ORR)=CR+PR |
| disease control rate (DCR) | Up to 12 months | disease control rate (DCR) |
| Safety as measured by number and grade of adverse events | Up to 3 years | Classification, frequency, and severity of drug-related adverse events |
Countries
China
Outcome results
None listed