The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus immunotherapy with concurrent chemoradiotherapy (CCRT) or RT alone in patients with stage III-IVa nasopharyngeal carcinoma(NPC), in order to confirm the value of Immunotherapy and concurrent chemotherapy in NPC patients.
Patients Patients with stage III-Iva(except T3N0M0) non-keratinizing NPC (UICC/AJCC 8th edition) are randomly assigned to receive immunotherapy and induction chemotherapy plus CCRT or RT alone. Patients in both groups receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. The immunotherapy and induction chemotherapy plus CCRT group receive cisplatin 80-100 mg/m² every 3 weeks for 2 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. Our primary endpoint is failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
476
IMRT without concurrent cisplatin chemotherapy
IMRT with concurrent cisplatin chemotherapy
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, China
Failure-free survival
Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first
Time frame: 3 years
Overall survival
Overall survival is calculated from randomization to death from any cause
Time frame: 3 years
Locoregional failure-free survival
Locoregional failure-free survival is calculated from randomization to the first locoregional failure
Time frame: 3 years
Distant failure-free survival
Distant failure-free survival is calculated from randomization to the first remote failure
Time frame: 3 years
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