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Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer

NCT06143761 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 206

Last updated 2023-11-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jinsong Li · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06143761 on ClinicalTrials.gov