This trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Sintilimab 200mg ivdrip, every 3 weeks for 6 cycles
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
SUN YAT-SEN UNIVERSITY cANCER CENTER
Guangzhou, Guangdong, China
Immune-related adverse events (irAEs) and serious adverse events (irSAEs)
Graded according to CTCAE V5.0
Time frame: From the date of informed consent to 100 days after treatment
All adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0
Time frame: From the date of informed consent to 100 days after treatment
The proportion of patients who completed radiation within 8 weeks
Time frame: 8 weeks
The proportion of patients who completed 6 cycles of sintilimab
Time frame: From the date of informed consent to the end of treatment, assessed up to 20 weeks.
Failure-free survival
calculated from the date of informed consent to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
Time frame: 3 years
Overall survival
calculated from the date of informed consent to the date of death from any cause.
Time frame: 3 years
Distant failure-free survival
calculated from the date of informed consent to the date of distant metastasis.
Time frame: 3 years
Locoregional failure-free survival
calculated from the date of informed consent to the the date of locoregional persistence or 1st locoregional recurrence.
Time frame: 3 years
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Definitive IMRT of 66-70Gy will be given in six to seven weeks.