This trial plans to enroll patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or 3 cycles of induction chemotherapy with gemcitabine and cisplatin and radiation plus Camrelizumab. All patients will receive intensity-modulated radiotherapy (IMRT). Camrelizumab will begin on day 1 of induction chemotherapy every 3 weeks for 3 cycles and continue every 2 weeks for 9 cycles.
Objectives:To investigate the clinical efficacy of camrelizumab in the treatment of locoregionally-advanced nasopharyngeal carcinoma (LANPC). Outline:Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.
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
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Guangxi Nanxishan hospital
Guilin, Guangxi, China
RECRUITINGGuilin Medical University
Guilin, Guangxi, China
RECRUITINGLaibin People's Hospital
Laibin, Guangxi, China
RECRUITINGLinshan people's hospital
Linshan, Guangxi, China
RECRUITINGWuzhou Red Cross Hospital
Wuzhou, Guangxi, China
NOT_YET_RECRUITINGProgress-free survival (PFS)
Calculated from randomization to the date of progression or death from any cause, whichever occurred first.
Time frame: 3 years
Overall survival (OS)
Calculated from randomization to the date of death from any cause.
Time frame: 3 years
Distant Metastasis-free survival (DMFS)
Calculated from randomization to the date of first distant metastasis.
Time frame: 3 years
Locoregional failure-free survival (LRRFS)
Calculated from randomization to the date of locoregional relapse.
Time frame: 3 years
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.
Time frame: 3 years
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