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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
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To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab and chemotherapy combined with endoscopic surgery | Experimental | Camrelizumab and chemotherapy combined with endoscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 2 cycles Camrelizumab before endoscopic surgery and one year after |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 2 year Overall Survival rate | From date of first treatment until the date of death from any cause, up to 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence free survival | the date of first treatment to local failure or death | From date of first treatment until the date of local recurrence or death from any cause, up to 4 years. |
| Progression free survival |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life-（EORTC QLQ) - C30 version3.0 | using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | From date of first treatment to the end of study, at each visit, up to 4 years. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaole Song, MD | Contact | 15821388769 | jxfxsxl@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongmeng Yu, MD,PHD | Eye&ENT Hospital,Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| Chemotherapy | Drug | 2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery |
|
| endoscopic surgery | Procedure | standard endoscopic surgery for recurrent nasopharyngeal carcinoma |
|
the date of first treatment to the first recording of disease progression or death from any cause.
| From date of first treatment until the date of disease progression or death from any cause, up to 4 years. |
| Rate of negative margin | negative margin rate according to pathology report | At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years. |
| distant metastasis free survival | the date of first treatment to distant metastasis or death | From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years. |
| pathologic complete remission | pathologic complete remission | At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years. |
| quality of life-（EORTC QLQ) - H&N35 | using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ）- H&N35，All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems. | From date of first treatment to the end of study, at each visit, up to 4 years. |
| adverse effect | Using CTCAE Version5.0 to evaluate related adverse effect | From date of first treatment to the end of study, up to 4 years. |
| immune related adverse effect | Using CTCAE Version5.0 to evaluate immune related adverse effect | From date of first treatment to the end of study, up to 4 years. |
| Fujian Provincial Hospital | Not yet recruiting | Fuzhou | Fujian | China |
|
| Shenzhen Second People's Hospital | Not yet recruiting | Shenzhen | Guangdong | China |
|
| The People's Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Nanning | Guangxi | China |
|
| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
|
| Eye& ENT Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
|
| Shanghai Zhongshan Hospital,Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D004358 | Drug Therapy |
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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