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The goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared to GP induction chemotherapy. Participants will be randomly divided into two induction treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine, nimotuzumab and toripalimab induction treatment | Experimental | Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 every 3 weeks for two cycles. nimotuzumanb 400mg every 3 weeks for two cycles. toripalimab 240mg every 3 weeks for two cycles. |
|
| gemcitabine and cisplatin | Active Comparator | Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 and cisplatin at a dose of 80 mg per square meter on day 1 were administered intravenously once every 3 weeks for two cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine,nimotuzumab, toripalimab | Drug | same as before |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | the proportion of patients who achieve complete response and partial response after induction therapy | three weeks after induction therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year overall survival | 2-year survival rate of patients enrolled in this study | From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months |
| 2-year distant metastasis-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | treatment-related adverse events during treatment and follow-up time | through study completion, an average of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | 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 |
|---|---|
| D000093542 | Gemcitabine |
| C501466 | nimotuzumab |
| C000656314 | toripalimab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| gemcitabine, cisplatin | Drug | same as before |
|
|
2-year distant metastasis-free survival rate of patients enrolled in this study
| From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months |
| 2-year local regional recurrence-free survival | 2-year local regional recurrence-free survival rate of patients enrolled in this study | From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |