Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial
— Redbull-1Official 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
Verified date | June 2023 |
Source | Biotech Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 .
Status | Completed |
Enrollment | 1931 |
Est. completion date | April 30, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
China | The General Hospital of the People's Liberation Army | Beijing | Beijing |
China | Sun Yat-sen University Cancer Centre | Guangzhou | Guangdong |
China | Tianjin Cancer Hospital | Tianjin | Tianjin |
China | First Affiliated Hospital of Xi 'an Jiaotong University | Xi'an | Shannxi |
Lead Sponsor | Collaborator |
---|---|
Biotech Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year overall survival (OS) rate | 3-year overall survival (OS) rate | Up to 3 years | |
Secondary | 3-year progression-free survival (PFS) rate | 3-year progression-free survival (PFS) rate | Up to 3 years | |
Secondary | 3-year Local-regional control (LRC) rate | 3-year Local-regional control (LRC) rate | Up to 3 years | |
Secondary | objective response rate (ORR) | objective response rate (ORR)=CR+PR | Up to 12 months | |
Secondary | disease control rate (DCR) | disease control rate (DCR) | Up to 12 months | |
Secondary | Safety as measured by number and grade of adverse events | Classification, frequency, and severity of drug-related adverse events | Up to 3 years |
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