Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer (NCT06143761) | Clinical Trial Compass
CompletedNot Applicable
Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer
China206 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival (OS)
Timeframe: 2 years
2
Disease-free survival （DFS）
Timeframe: 2 years
Trial details
NCT IDNCT06143761
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University