This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
total 60-66Gy, 1.8-2.0Gy/f/day
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGPeking University Third Hospital
Beijing, China
RECRUITINGOverall survival
Defined as the time from date of recruitment to death from any cause.
Time frame: three years
Failure-free survival
Defined as the time from date of recruitment to documented relapse or death from any cause.
Time frame: three years
Objective response rate through study completion, an average of nine months
The rate of patients get CR or PR after treatment
Time frame: through study completion, an average of nine months
Disease control rate through study completion, an average of nine months
The rate of patients get CR or PR or SD after treatment
Time frame: through study completion, an average of nine months
Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years
Incidence of nasopharyngeal necrosis and hemorrhage after receiving treatment
Time frame: up to three-year follow-up
Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0) for chemotherapy and immunotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.
Time frame: through study completion, an average of nine months
Late toxicity
Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.
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Sichuan Cancer Hospital
Chengdu, China
NOT_YET_RECRUITINGFujian Province Cancer Hospital
Fuzhou, China
NOT_YET_RECRUITINGGuizhou Cancer Hospital
Guiyang, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, China
RECRUITINGJiangxi Cancer Hospital
Nanchang, China
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
Time frame: three years
Quality of life through study completion, up to 3 years
Evaluated with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L).
Time frame: up to three-year follow-up