The purpose of this study is to evaluate the efficacy and safety of intensity-modulated radiation therapy combined with toripalimab in patients with the unresectable locally recurrent nasopharyngeal carcinoma.
This is an open-label ,single center ,non-randomized, single arm exploratory study. All eligible patients presented with non-keratinizing NPC and stage rT0-4N1-3M0 /rT2-4N0M0 are assigned to receive IMRT combined with toripalimab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks) will be administered as an intravenous infusion over 60 minutes.
intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
ORR
Objective Response Rate
Time frame: Through study completion, an average of 1 year
PFS
Progression-Free Survival is defined as time interval from recruitment to tumor progression or censoring.
Time frame: up to 3 years
OS
Overall Survival is defined as time interval from recruitment to all-caused death or censoring.
Time frame: up to 3 years
Incidence of Treatment-Emergent Adverse Events
Adverse events (AE), Serious Adverse Event(SAE)
Time frame: Through study completion, an average of half a year
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