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The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the combination of camrelizumab and standard treatment | Experimental | camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy. |
|
| the combination of nimotuzumab and standard treatment | Experimental | nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy. |
|
| standard treatment | Active Comparator | the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1,8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | camrelizumab 200mg q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Defined from date of randomization to date of first documentation of progression or death due to any cause | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up. | 3 years |
| Toxicities | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengrun Du | Contact | +86-15001733593 | duchengrun@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Universtiy Shanghai Cancer Centre | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Nimotuzumab |
| Drug |
nimotuzumab 200mg qw |
|
| neoadjuvant chemotherapy and CCRT | Drug | the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1,8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region. |
|
| 3 years |
| 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 |
|---|---|
| C000631724 | camrelizumab |
| C501466 | nimotuzumab |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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