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Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirelizumab plus salvage surgery | Experimental | Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma |
|
| salvage surgery alone | Active Comparator | Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirelizumab | Drug | Tirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival(PFS) | Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | Defined as the time interval from randomization to death due to any cause. | 2 years |
| Locoregional failure-free survival(LRRFS) | The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanpeng Li, MD | Contact | 13262856870 | 18879117831@163.com | |
| Li Hu, MD | Contact | 18917786049 | hl318ent@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40413023 | Derived | Li W, Wang T, Xu H, Liu Q, Zhang H, Yang Y, Sun X, Yu H, Gu Y, Li H, Ding H, Wang D. Tislelizumab as adjuvant therapy following endoscopic surgery for resectable recurrent nasopharyngeal carcinoma: a randomized clinical trial. J Immunother Cancer. 2025 May 24;13(5):e011998. doi: 10.1136/jitc-2025-011998. |
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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 |
|---|---|
| C000711728 | spartalizumab |
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|
| salvage surgery | Procedure | Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor |
|
| 2 years |
| Distant metastasis-free survival(DMFS) | The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit. | 2 years |
| Incidence of treatment related complications | Incidence of treatment related complications of tirelizumab or surgical treatment during follow-up | 2 years |
| 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 |