Status:

COMPLETED

Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer

Lead Sponsor:

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

Conditions:

Oral Cancer

Eligibility:

All Genders

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 analyze...

Eligibility Criteria

Inclusion

  • Patients with advanced OSCC who received NACI before surgery
  • Confirmation of primary OSCC by two experienced pathologists;
  • Clinical stage III/ IVA (cT1-2/cN1-2/M0 or cT3-4a/cN0-2/M0) according to the 8th Edition of American Joint Committee on Cancer (AJCC) guideline;
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
  • No prior anti-cancer therapy;
  • Locally resectable advanced tumor evaluated by a head and neck surgeon.
  • Advanced OSCC patients who only received surgery
  • A histopathologic diagnosis of primary OSCC;
  • A clinical stage of III/IVA (AJCC, 8th edition);
  • An ECOG performance status of 0 to 1.

Exclusion

  • Patients with advanced OSCC who received NACI before surgery
  • Patients with other pathological types, without NACI or Surgery;
  • Incomplete pre-treatment data;
  • Lost to follow up were excluded from the study.
  • Advanced OSCC patients who only received surgery
  • Patients who had received other therapies targeting the head and neck region before the surgery or those with evidence of recurrence or metastasis, as assessed by physical examination reports or imaging studies before surgery
  • Lost to follow up.

Key Trial Info

Start Date :

December 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 30 2022

Estimated Enrollment :

206 Patients enrolled

Trial Details

Trial ID

NCT06143761

Start Date

December 1 2020

End Date

June 30 2022

Last Update

November 22 2023

Active Locations (1)

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Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China, 510120