Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer

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.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

PD-1 inhibitor+carboplatin+albumin-bound paclitaxel

Drug

A comparative evaluation of patient prognosis between those who received neoadjuvant chemoimmunotherapy-surgery treatment and those who underwent surgery alone.

Primary outcomes

Overall survival (OS)

Time frame: 2 years

The time(years) from day 1 of study treatment until death from any cause.
Disease-free survival （DFS）

Time frame: 2 years

DFS(by months) is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease DFS is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease relapse.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: HNC-SYSU-005

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Nov 22, 2023
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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