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This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 antibody plus chemoradiotherapy | Experimental | Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles. |
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| Chemoradiotherapy | Active Comparator | Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 blocking antibody | Drug | Toripalimab 240mg, D1, every 3 weeks per cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From date of randomisation to death | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | From date of randomisation to disease progression | 3 years |
| Short-term effects | Patient's objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Miao | Contact | 02087342638 | miaojingjing90@163.com | |
| Chong Zhao | Contact | 02087342638 | zhaochong@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 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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| GP | Drug | Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles |
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| IMRT | Radiation | IMRT 60-66Gy, 1.8-2.0Gy/f/day |
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| through study completion, an average of 2 months |
| Rate of patients with acute toxicities | Evaluating with CTCAE v5.0 | through study completion, an average of 2 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 3 years |
| Peking University Third Hospital | Not yet recruiting | Beijing | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | China |
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| Fujian Province Cancer Hospital | Not yet recruiting | Fuzhou | China |
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| Guizhou Cancer Hospital | Recruiting | Guiyang | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | China |
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| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | China |
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| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | China |
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| Xijing Hospital | Recruiting | Xi'an | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | China |
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| 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 |