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
Guangxi Nanxishan hospital
Guilin, Guangxi, China
RECRUITINGGuilin Medical University
Guilin, Guangxi, China
RECRUITINGLaibin People's Hospital
Laibin, Guangxi, China
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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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
Linshan people's hospital
Linshan, Guangxi, China
RECRUITINGWuzhou Red Cross Hospital
Wuzhou, Guangxi, China
NOT_YET_RECRUITING