For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
260mg/m\^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGPathological Complete Response (PCR)
Time frame: From neoadjuvant therapy to surgical resection, up to 6 weeks
Major Pathological Response (MPR)
In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
Time frame: From neoadjuvant therapy to surgical resection, up to 6 weeks
3-year Disease-free survival (DFS) rate
Time from randomization to disease recurrence or death of any cause
Time frame: 3-years after surgery
3-year overall survival(OS)rate
The proportion of all study cases in which no death from any cause occurred within 3 years after surgery
Time frame: 3-years after surgery
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