This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGPeking University Third Hospital
Beijing, China
NOT_YET_RECRUITINGOverall survival
From date of randomisation to death
Time frame: 3 years
Progression free survival
From date of randomisation to disease progression
Time frame: 3 years
Short-term effects
Patient's objective response rate
Time frame: through study completion, an average of 2 months
Rate of patients with acute toxicities
Evaluating with CTCAE v5.0
Time frame: through study completion, an average of 2 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 3 years
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Sichuan Cancer Hospital
Chengdu, China
NOT_YET_RECRUITINGFujian Province Cancer Hospital
Fuzhou, China
NOT_YET_RECRUITINGGuizhou Cancer Hospital
Guiyang, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, China
NOT_YET_RECRUITINGJiangxi Cancer Hospital
Nanchang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
NOT_YET_RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, China
RECRUITING...and 2 more locations