Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer (HNC-SYSU-005)

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer
• Intervention / Treatment: Drug: PD-1 inhibitor+carboplatin+albumin-bound paclitaxel

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
neoadjuvant chemoimmunotherapy+surgery; Patients who underwent neoadjuvant chemoimmunotherapy before surgery	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.
surgery; Patients who accepted the surgery alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival (OS)	The time(years) from day 1 of study treatment until death from any cause.	2 years

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Jinsong Li, Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: neoadjuvant chemoimmunotherapy, advanced oral squamous cell carcinoma, therapeutic response, predictive marker, prognosis
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Mouth Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel; Immune Checkpoint Inhibitors
• Other Study ID Numbers: SYSKY-2023-184-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No