Redbull-1: A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | 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).
|
| 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. |
Outcome Measures
Primary Outcome Measures
- 3-year overall survival (OS) rate [Up to 3 years]
3-year overall survival (OS) rate
Secondary Outcome Measures
- 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 [Up to 3 years]
Classification, frequency, and severity of drug-related adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years old, no gender limitation;
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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).
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Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018;
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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:
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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);
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Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab;
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Lack of critical evaluation information.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
| 2 | The General Hospital of the People's Liberation Army | Beijing | Beijing | China | 100853 |
| 3 | Sun Yat-sen University Cancer Centre | Guangzhou | Guangdong | China | 510000 |
| 4 | First Affiliated Hospital of Xi 'an Jiaotong University | Xi'an | Shannxi | China | 710061 |
| 5 | Tianjin Cancer Hospital | Tianjin | Tianjin | China | 300060 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- BPL-Nimo-SCCHN-RWS-1