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| Name | Class |
|---|---|
| Wuzhou Red Cross Hospital | OTHER |
| Guangxi Nanxishan Hospital | UNKNOWN |
| Laibin People's Hospital | OTHER |
| Lingshan people's Hospital |
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This trial plans to enroll patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or 3 cycles of induction chemotherapy with gemcitabine and cisplatin and radiation plus Camrelizumab. All patients will receive intensity-modulated radiotherapy (IMRT). Camrelizumab will begin on day 1 of induction chemotherapy every 3 weeks for 3 cycles and continue every 2 weeks for 9 cycles.
Objectives:To investigate the clinical efficacy of camrelizumab in the treatment of locoregionally-advanced nasopharyngeal carcinoma (LANPC).
Outline:Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab arm | Experimental | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter. |
|
| Chemoradiation arm | Active Comparator | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | Calculated from randomization to the date of progression or death from any cause, whichever occurred first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Calculated from randomization to the date of death from any cause. | 3 years |
| Distant Metastasis-free survival (DMFS) | Calculated from randomization to the date of first distant metastasis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Jiang, Ph.D. | Contact | +86-773-2882906 | weijiang@glmc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bin Zhang, M.D. | Wuzhou Red Cross Hospital | Principal Investigator |
| Yu-fei Pan, M.D. | Guangxi Nanxishan Hospital | Principal Investigator |
| Yi-xin Su, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Nanxishan hospital | Recruiting | Guilin | Guangxi | 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 |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C000711728 | spartalizumab |
| D000093542 | Gemcitabine |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| UNKNOWN |
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| Gemcitabine | Drug | Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation |
|
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| Induction Cisplatin | Drug | Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation |
|
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| intensity-modulated radiotherapy | Radiation | Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions. |
|
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| Concurrent cisplatin | Drug | Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation |
|
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| 3 years |
| Locoregional failure-free survival (LRRFS) | Calculated from randomization to the date of locoregional relapse. | 3 years |
| Adverse events (AEs) and serious adverse events (SAEs) | Graded according to CTCAE V5.0. | 3 years |
| Lingshan people's Hospital |
| Principal Investigator |
| Jian Zhang, M.D. | Laibin People's Hospital | Principal Investigator |
| Guilin Medical University | Recruiting | Guilin | Guangxi | China |
|
| Laibin People's Hospital | Recruiting | Laibin | Guangxi | China |
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| Linshan people's hospital | Recruiting | Linshan | Guangxi | China |
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| Wuzhou Red Cross Hospital | Not yet recruiting | Wuzhou | Guangxi | China |
|
| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |