To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
postoperative radiotherapy with a dose of 60-66Gy
JS001 240mg every three week
Guopei Zhu
Shanghai, China
RECRUITINGDisease free survival
Time frame: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Overall survival
Time frame: from date of enrollment until death from any cause, assessed up to 2 years
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment
Acute toxicity profiles, graded according to the NCI CTCAE version 4.0
Time frame: up to 3 months after completion of radiotherapy
Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0
Late toxicity profiles, graded according to the NCI CTCAE version 4.0
Time frame: from 3 months after completion of radiotherapy up to 2 years
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