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.
Study Type
OBSERVATIONAL
Enrollment
43
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.
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGProgress-free survival (PFS)
Defined from date of recruit to date of first documentation of progression or death due to any cause.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 5 years
Serious adverse events (SAE)
Serious adverse events (SAE) is defined as either death, life-threatening, or Permanent or severe disability/incapacity.
Time frame: 5 years
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