NCT06143761

Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer

A Pilot Study of Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 1.1) 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 4.0. 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.

Conditions

• Oral Cancer

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor+carboplatin+albumin-bound paclitaxel	A comparative evaluation of patient prognosis between those who received neoadjuvant chemoimmunotherapy-surgery treatment and those who underwent surgery alone.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2023-11-22
• Last updated: 2023-11-22

Locations

1 site across 1 country: China