This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
Cisplatin and Gemcitabine
IMRT 60-66Gy, 1.8-2.0Gy/f/day
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Overall survival
From date of recruitment to death
Time frame: 2 years
Objective response rate
Patient's short-term effect
Time frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Disease control rate
Patient's short-term effect
Time frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Progression free survival
From date of recruitment to disease progression or death
Time frame: 2 years
Adverse effects
Evaluating with CTCAE v5.0
Time frame: through study completion, an average of 3 months
Quality of life: EuroQoL 5 dimension
Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
Time frame: through whole study, an average of 2 years
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