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The purpose of this study is to evaluate the efficacy and safety of intensity-modulated radiation therapy combined with toripalimab in patients with the unresectable locally recurrent nasopharyngeal carcinoma.
This is an open-label ,single center ,non-randomized, single arm exploratory study. All eligible patients presented with non-keratinizing NPC and stage rT0-4N1-3M0 /rT2-4N0M0 are assigned to receive IMRT combined with toripalimab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab +Radiotherapy | Experimental | Radiotherapy, intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks ) will be administered as an intravenous infusion over 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolipalimab | Drug | Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks) will be administered as an intravenous infusion over 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-Free Survival is defined as time interval from recruitment to tumor progression or censoring. | up to 3 years |
| OS | Overall Survival is defined as time interval from recruitment to all-caused death or censoring. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Yuan Chen, MD,PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34782428 | Derived | Hua Y, You R, Wang Z, Huang P, Lin M, Ouyang Y, Xie Y, Zou X, Liu Y, Duan C, Liu Y, Gu C, Liu R, Yang Q, Jiang R, Zhang M, Ding X, Chen S, Lin C, Sun R, Chen M. Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial. J Immunother Cancer. 2021 Nov;9(11):e003290. doi: 10.1136/jitc-2021-003290. |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D009303 | Nasopharyngeal Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069475 | Re-Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D019233 | Retreatment |
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|
| Reirradiation | Radiation | intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks |
|
| up to 3 years |
| Incidence of Treatment-Emergent Adverse Events | Adverse events (AE), Serious Adverse Event(SAE) | Through study completion, an average of half a year |
| D010610 |
| Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009371 | Neoplasms by Site |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |