Clinical trial NCT06143761: Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer
Official title: A Pilot Study of Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cancer
Keywords: neoadjuvant chemoimmunotherapy, advanced oral squamous cell carcinoma, therapeutic response, predictive marker, prognosis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients underwent NACI before surgery
* Patients accepted the surgery alone.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
measure: Disease-free survival （DFS）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jinsong Li
role: PRINCIPAL_INVESTIGATOR
References: