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Clinical Trial Summary

The purpose of this prospective, single-center, single-arm, open-label II phase observation clinical trial is to evaluate the efficacy and safety of Pembrolizumab immunoadjuvant therapy in patients with stage III-IVA oral squamous cell carcinoma. The primary end point is the pathological tumor remission rate of the primary tumor and regional lymph nodes after neoadjuvant immunotherapy (pTR-2: the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections > 50%). The secondary endpoints are 1-year disease-free survival (DFS), 1-year overall survival (OS) and the incidence of adverse events, compared with historical data. In addition, we will check the relevant immune indicators, such as PD-L1 and CPS scores.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05578170
Study type Observational
Source Nanfang Hospital of Southern Medical University
Contact
Status Recruiting
Phase
Start date June 1, 2022
Completion date December 31, 2024

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