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The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) . Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.
The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) locoregionally advanced nasopharyngeal carcinoma (LANPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab (200mg q3wk), and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. IMRT:PGTVnx: 69.96 Gy /33f, PGTVnd: 66~70 Gy /33f, PCTVnd: 63~64 Gy/33f, PCTV1: 60~62 Gy/33f, PCTV2: 54~56 Gy/33f. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab+Chemoradiotherapy | Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab (PD-1 Antibody) | Drug | Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | Defined from date of recruit to date of first documentation of progression or death due to any cause. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined from date of recruit to date of first documentation of death from any cause or censored at the date of the last follow-up. | 5 years |
| Locoregional Relapse-Free Survival (LRRFS) |
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Inclusion Criteria:
Exclusion Criteria:
1.Age > 70 or < 18. 2.Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml 3.Hepatitis C virus (HCV) antibody positive 4.Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment.
5.Has a known history of interstitial lung disease. 6.Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
7.Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
8.Is pregnant or breastfeeding. 9.Has a history of other malignancies except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.
10.Has known allergy to large molecule protein products or any compound of sintilimab.
11.Has a known history of human immunodeficiency virus (HIV) infection. 12.Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a
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High-risk Locoregionally-advanced nasopharyngeal carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Dong Zhu, Doctor | Contact | 13978873616 | zhuxiaodong83@163.com | |
| Ling Li, Master | Contact | 15977737210 | lilingmoon99@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Dong Zhu, Doctor | Cancer Hospital of Guangxi Medical University | Principal Investigator |
| Ling Li, Master | Cancer Hospital of Guangxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | 530021 | 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 |
|---|---|
| C000632826 | sintilimab |
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Defined from date of recruit to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
| 5 years |
| Distant Metastasis-Free Survival (DMFS) | Defined from date of recruit to date of first documentation of distant metastases or until the date of the last followup visit. | 5 years |
| Objective Response Rate (ORR) | An objective response is defined as 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). | through study completion, an average of 1 year |
| Incidence rate of adverse events (AEs) | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 | 5 years |
| Serious adverse events (SAE) | Serious adverse events (SAE) is defined as either death, life-threatening, or Permanent or severe disability/incapacity. | 5 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 |