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This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | IC with anti-PD1 mab+CCRT+anti-PD1 mab |
|
| Arm B | Active Comparator | IC+CCRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody | Drug | neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | From date of randomization to date of first documentation of progression or death due to any cause. | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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 year |
| Distant Metastasis-Free Survival (DMFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingao Li | Contact | 86-791-88300252 | lijingao@hotmail.com | |
| Tianzhu Lu, PhD | Contact | 15270186250 | lutianzhu2008@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingao Li, M.D. | Jiangxi Provincial Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | 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 |
|---|---|
| C000711728 | spartalizumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles |
|
| Cisplatin | Drug | neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT |
|
| IMRT | Radiation | 70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions |
|
From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit.
| 3 year |
| Locoregional Relapse-Free Survival (LRRFS) | From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit. | 3 year |
| Objective Response Rate (ORR) | Either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). | within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy |
| adverse events (AEs) | Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0 | 3 year |
| Suizhou Central Hospital | Recruiting | Suizhou | Hubei | China |
|
| Ganzhou Cancer Hospital | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| First Affiliated hospital of Gannan Medical University | Recruiting | Guangzhou | Jiangxi | 341000 | China |
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| Jiujiang University Affiliated Hospital | Recruiting | Jiujiang | Jiangxi | 332000 | China |
|
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
|
| Pingxiang Peoples' Hospital | Recruiting | Pingxiang | Jiangxi | 330029 | 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |