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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
| Wuhan TongJi Hospital | OTHER |
| Xijing hospital of The fourth military medical university | UNKNOWN |
| Dongguan People's Hospital |
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This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR+PD-1+Chemo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR Antibody | Drug | 6 cycles for combined therapy. Maintenance for 1 year. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From the date of recruiting to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | All adverse event or serious adverse event that occurred during the study period according to CTCAE v 5.0. | Up to 16 months |
| Overall survival (OS) | From the date of recruiting to the date of death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Chong PhD. | Contact | 139022061610 | zhaochong@sysucc.org.cn | |
| Miao Jingjing MD. | Contact | 13631355201 | miaojj@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| OTHER_GOV |
| Liuzhou Workers' Hospital | OTHER_GOV |
| Chongqing University Cancer Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
| Fujian Province Tumor Hospital | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
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| PD-1 antibody |
| Drug |
6 cycles for combined therapy. Maintenance for 1 year. |
|
| Gemcitabine, Cisplatin | Drug | 6 cycles for combined therapy. |
|
| IMRT | Radiation | IMRT for primary lesion |
|
| 1 year |
| Objective response rate (ORR) | The percentage of patients with CR and PR assessed according to RECIST v1.1. | 1 year |
| Disease control rate (DCR) | The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1. | 1 year |
| Quality of life (QoL) | Assessed by EQ-5D-5L questionnaire | 1 year |
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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