Clinical Trial

The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC

Not Yet Recruiting Phase 2
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Summary
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.
Trial Details
NCT Number NCT06895369
Lead Sponsor Sir Run Run Shaw Hospital
Conditions Squamous Cell Carcinoma of Head and Neck
Enrollment 30 participants
Start Date 2025-05-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2033-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-26