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Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer

NCT ID: NCT06143761

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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neoadjuvant chemoimmunotherapy+surgery

Patients who underwent neoadjuvant chemoimmunotherapy before surgery

PD-1 inhibitor+carboplatin+albumin-bound paclitaxel

Intervention Type DRUG

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

surgery

Patients who accepted the surgery alone

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinsong Li

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSKY-2023-184-01

Identifier Type: -

Identifier Source: org_study_id