To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total
Intensity modulated radiotherapy
Yanqun Xiang
Guangzhou, Guangdong, China
RECRUITINGAdverse events
The severity of adverse events will be determined by the investigator based on CTCAE v 5.0
Time frame: Recent evaluation: 3 months after the end of treatment;Long-term follow-up: 1~5 years after the end of treatment
overall survival (OS)
Patients in clinical trials were randomized to the time of death from any cause
Time frame: 2 years
progression-free survival (PFS)
The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause
Time frame: 2 years
Distant metastasis-free survival(DMFS)
Patients in clinical trials were randomized to the time of distant metastasis
Time frame: 2 years
Response rate (based on RECIST ver1.1)
According to the remission assessment criteria of solid tumors,divided into CR, PR, SD, PD. CR(complete response) All target lesions disappeared and no new lesions appeared PR ( partial response) reduction of the sum of the largest diameters of target lesions by ≥30%) SD(stable disease)the sum of the largest diameters of target lesions does not shrink to PR, or increases to PD PD(progressive disease) The sum of the largest diameters of target lesions increases by at least 20%, or new lesions appear
Time frame: Recent evaluation: 3 months after the end of treatment;Long-term follow-up: 1~5 years after the end of treatment
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