drugset / Trial / NCT06895369

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

NCT06895369

Phase 2 Not yet recruiting 30 enrolled Sir Run Run Shaw Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-05-01
Primary completion
2028-12-31
Completion
2033-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pucotenlimab Monoclonal antibody
Background Cisplatin Other / unclassified
Background Docetaxel Small molecule