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.
Patients with histologically confirmed Non-keratinizing nasopharyngeal carcinoma.
Tumor staged as III-IVA (AJCC 8th, T3-4N2-3M0).
Eastern Cooperative Oncology Group performance status ≤1.
Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
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.
High-risk Locoregionally-advanced nasopharyngeal carcinoma
Cohort
Prospective
Sintilimab (PD-1 Antibody)
DrugPatients 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.
Progress-free survival (PFS)
Defined from date of recruit to date of first documentation of progression or death due to any cause.
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.
Locoregional Relapse-Free Survival (LRRFS)
Defined from date of recruit to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
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.
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).
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