OncoMatch/Clinical Trials/NCT05446467
Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
Is NCT05446467 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies pembrolizumab+cisplatin + 5-FU for head and neck squamous cell carcinoma.
Treatment: pembrolizumab+cisplatin + 5-FU — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (CPS PD-L1 immunohistochemical examination (22C3 DAKO) required; no threshold specified)
Have sufficient tumour tissue samples available for CPS PD-L1 immunohistochemical examination (22C3 DAKO)
Excluded: HPV p16 positive
HPV p16 positive oropharyngeal cancer [excluded]
Disease stage
Required: Stage III, IV A (AJCC 8th edition)
Patients diagnosed with head and neck squamous cell carcinoma with stage III and IV A without distant metastasis according to AJCC staging (8th editon)... Patients with local advanced head and neck squamous cell carcinoma stage T4B and/or N3 [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any disease-related therapy
Exception: diagnostic biopsies on primary lesions
Lab requirements
Blood counts
ANC≥1.5×10^9 /L, platelets ≥100×10^9 /L, Hb≥ 90 g/L, WBC ≥3.0×10^9 /L before enrollment, no blood transfusion and bleeding tendency within 7 days
Kidney function
Serum creatinine ≤1.5 or creatinine clearance >50 mL/min
Liver function
ALT, AST and ALP ≤ 2.5 × ULN; Serum bilirubin ≤ 1.5 × ULN, for patients with known Gilbert disease, serum bilirubin ≤ 3 x ULN
No abvious signs of hematological disorders, ANC≥1.5×10^9 /L, platelets ≥100×10^9 /L, Hb≥ 90 g/L,WBC ≥3.0×10^9 /L before enrollment, no blood transfusion and bleeding tendency within 7 days; ALT,AST and ALP ≤ 2.5 × 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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