Safety and Efficacy of Pembrolizumab in Combination With Low-dose PF (Cisplatin and 5-Fluorouracil) as Neoadjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multi-center, Single-arm Clinical Study Trial
A phase Ⅱ open label multi-cencter clinical trail to evaluate the efficacy and safety of pembrolizumab combined with low-dose PF (cisplatin + 5-fluorouracil) in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma
• Age ≥ 18 years old, ≤ 85 years old
• Histologically or cytologically proven squamous cell carcinoma of the head and neck; Patients diagnosed with head and neck squamous cell carcinoma with stage III and IV A without distant metastasis according to AJCC staging (8th editon), including squamous cell carcinoma of oropharyngeal (P16-), oral cavity, hypopharyngeal and larynx
• Measurable primary lesions per RECIST 1.1 criteria
• Treatment-naive patients without any previous disease-related therapy (except for diagnostic biopsies on primary lesions)
• ECOG performance status of 0 or 1
• Selective standard surgery+ standard adjuvant chemo-radiotherapy/radiotherapy as judged by the investigator
• No active autoimmune disease
• No concurrent malignancy
• Life expectancy is estimated to be over 3 months
⁃ Have sufficient tumour tissue samples available for CPS PD-L1 immunohistochemical examination (22C3 DAKO)
⁃ No abvious signs of hematological disorders, ANC≥1.5×109 /L, platelets ≥100×109 /L, Hb≥ 90 g/L,WBC ≥3.0×109 /L before enrollment, no blood transfusion and bleeding tendency within 7 days
⁃ ALT,AST and ALP ≤ 2.5 × upper limit of normal (ULN); Serum bilirubin ≤ 1.5 × ULN, for patients with known Gilbert disease, serum bilirubin ≤ 3 x ULN
⁃ Serum creatinine ≤1.5 or creatinine clearance\>50 mL/min
⁃ HPV status determined by p16 IHC, in situ hybridization, or by polymerase chain reaction-based assays
⁃ Able to understand this study, patient and (or) legal representative voluntarily agree to participate in this trial and sign informed consent