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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Patients of study group were all treated with chemoradiotherapy plus 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nimotuzumab | Drug | Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival (OS) rate | 3-year overall survival (OS) rate | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year progression-free survival (PFS) rate | 3-year progression-free survival (PFS) rate | Up to 3 years |
| 3-year Local-regional control (LRC) rate | 3-year Local-regional control (LRC) rate |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| The General Hospital of the People's Liberation Army |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| Up to 3 years |
| objective response rate (ORR) | objective response rate (ORR)=CR+PR | Up to 12 months |
| disease control rate (DCR) | disease control rate (DCR) | Up to 12 months |
| Safety as measured by number and grade of adverse events | Classification, frequency, and severity of drug-related adverse events | Up to 3 years |
| Beijing |
| Beijing Municipality |
| 100853 |
| China |
| Sun Yat-sen University Cancer Centre | Guangzhou | Guangdong | 510000 | China |
| First Affiliated Hospital of Xi 'an Jiaotong University | Xi'an | Shannxi | 710061 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |