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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment
Sir Run Run Shaw Hospital
Hanzhou, Zhejiang, China
Pathological complete response rate
Pathological complete response rate (pCR) after surgery
Time frame: The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.
Major pathological response rate
major pathological response rate (MPR) of the treatment regimen
Time frame: The anticipated completion date is within 3.5 months after the enrollment of the last patient, with the overall study expected to conclude within 2 years following the enrollment of the first patient.
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