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This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiotherapy+anti-PD-1 | Experimental | Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles. |
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| Chemoradiotherapy | Active Comparator | Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | 240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the time from date of recruitment to death from any cause. | three years |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | Defined as the time from date of recruitment to documented relapse or death from any cause. | three years |
| Objective response rate through study completion, an average of nine months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Miao, PhD | Contact | +8613631355201 | miaojj@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, MD PhD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | 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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| Chemotherapy | Drug | Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles |
|
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| Intensity modulated radiotherapy | Radiation | total 60-66Gy, 1.8-2.0Gy/f/day |
|
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The rate of patients get CR or PR after treatment
| through study completion, an average of nine months |
| Disease control rate through study completion, an average of nine months | The rate of patients get CR or PR or SD after treatment | through study completion, an average of nine months |
| Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years | Incidence of nasopharyngeal necrosis and hemorrhage after receiving treatment | up to three-year follow-up |
| Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0) | Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0) for chemotherapy and immunotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities. | through study completion, an average of nine months |
| Late toxicity | Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria. | three years |
| Quality of life through study completion, up to 3 years | Evaluated with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L). | up to three-year follow-up |
| Peking University Third Hospital | 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 | Not yet recruiting | Guiyang | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | China |
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| Jiangxi Cancer Hospital | 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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| 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 |
|---|---|
| C000656314 | toripalimab |
| D004358 | Drug Therapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
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