Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC).
Study Design: This is a single-arm interventional study. Intervention: Patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination.
Endpoints: Pathological complete response rate (pCR) after surgery, major pathological response rate (MPR) of the treatment regimen, disease-free survival (DFS), and overall survival (OS).
Hypothesis: The combination of pucotenlimab and TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced HNSCC is expected to improve pathological response rates and enhance patient prognosis.
Age: 18 to 70 years old.
Diagnosis: Histopathologically confirmed head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx, classified as Stage III or IV A according to the AJCC Cancer Staging Manual (8th Edition).
Measurable Disease: At least one measurable primary lesion per RECIST 1.1 criteria.
Treatment Status: Treatment-naïve patients with no prior therapy for the disease.
Cachexia or multiple organ failure.
Active autoimmune disease(s) requiring systemic treatment (excluding vitiligo, resolved childhood asthma/atopy, or controlled hypothyroidism on hormone replacement).
Concurrent second primary malignancy (e.g., esophageal cancer).
Severe active infection requiring systemic therapy.
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China