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This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 antibody plus chemoradiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 blocking antibody | Drug | Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From date of recruitment to death | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Patient's short-term effect | After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) |
| Disease control rate | Patient's short-term effect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, M.D | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| Label | URL |
|---|---|
| Home Page of Sun Yat-sen University Cancer Center | View source |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Chemotherapy | Drug | Cisplatin and Gemcitabine |
|
| IMRT | Radiation | IMRT 60-66Gy, 1.8-2.0Gy/f/day |
|
| After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) |
| Progression free survival | From date of recruitment to disease progression or death | 2 years |
| Adverse effects | Evaluating with CTCAE v5.0 | through study completion, an average of 3 months |
| Quality of life: EuroQoL 5 dimension | Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L) | through whole study, an average of 2 years |
| 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 |