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| Name | Class |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Zhujiang Hospital | OTHER |
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The aim of this study is to investigate the efficacy and safety of the "capecitabine combined with toripalimab maintenance regimen" in improving the first-line treatment of recurrent and metastatic nasopharyngeal carcinoma after receiving remission through chemotherapy combined with anti PD-1 monoclonal antibody standard regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine combined with toripalimab maintenance group | Experimental | Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle |
|
| Placebo combined with toripalimab maintenance group | Placebo Comparator | Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine/Placebo combined with toripalimab | Drug | Combined |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival is defined as the time interval between randomization and the first recording of tumor progression (evaluated according to RECIST 1.1 criteria, regardless of continued treatment) or death from any cause | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SunYat-senU | Guangzhou | Guangdong | 510060 | China |
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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 |
| 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 |
|---|---|
| D000069287 | Capecitabine |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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