NCT06143761

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

November 14, 2023

Last Update Submit

November 20, 2023

Conditions

Oral Cancer

Keywords

neoadjuvant chemoimmunotherapy, advanced oral squamous cell carcinoma, therapeutic response, predictive marker, prognosis

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    The time(years) from day 1 of study treatment until death from any cause.

    2 years

  • Disease-free survival （DFS）

    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.

    2 years

Study Arms (2)

neoadjuvant chemoimmunotherapy+surgery

Patients who underwent neoadjuvant chemoimmunotherapy before surgery

Drug: PD-1 inhibitor+carboplatin+albumin-bound paclitaxel

surgery

Patients who accepted the surgery alone

Interventions

PD-1 inhibitor+carboplatin+albumin-bound paclitaxelDRUG

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

neoadjuvant chemoimmunotherapy+surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Patients underwent NACI before surgery * Patients accepted the surgery alone.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Jinsong Li

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 22, 2023

Study Start

December 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

CN(1)