Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143761
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-14
Brief Title:
Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Pilot Study of Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HNC-SYSU-005
Brief Summary:
The goal of this observational study is to investigate the effectiveness of neoadjuvant chemoimmunotherapy NACI regimens in treating advanced oral squamous cell carcinoma OSCC patients We analyzed clinicopathologic features of advanced OSCC patients who received PD-1 inhibitors in combination with carboplatin and paclitaxel before surgical tumor resection between 2020 and 2022 The Response Evaluation Criteria in Solid Tumors RECIST version 11 and pathologic response were used to evaluate the efficacy of the NACI treatment Adverse events apparently related to NACI treatment were graded according to the Common Terminology Criteria for Adverse Events version 40 Disease-free survival DFS and overall survival OS were calculated using the Kaplan-Meier survival curves and compared using the log rank test Additionally we calculated the area under curve AUC to compare the predictive value of PD-L1 expression with baseline serum lipid biomarkers for patient response
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None