Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQunxing Li,MD
About this trial
This is a multicenter, open-label, randomized phase III clinical trial evaluating perioperative treatment with sintilimab combined with chemotherapy in patients with locally advanced oral squamous cell carcinoma.
Despite standard treatment with surgery followed by postoperative radiotherapy or chemoradiotherapy, patients with locally advanced oral squamous cell carcinoma remain at high risk of recurrence or metastasis. Recent evidence, including results from the KEYNOTE-689 study, suggests that perioperative immunotherapy may improve survival outcomes, and this approach has been incorporated into NCCN guidelines. Combining immunotherapy with chemotherapy may further improve prognosis in this patient population.
Eligible participants will be randomly assigned to either an experimental group or a control group. The experimental group will receive neoadjuvant sintilimab combined with chemotherapy followed by surgery and postoperative treatment based on pathological response. Patients with major pathological response (MPR) will receive adjuvant sintilimab, while patients without MPR will receive postoperative radiotherapy or concurrent chemoradiotherapy combined with sintilimab. The control group will receive standard treatment consisting of surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated.
The primary objective of the study is to compare event-free survival between the two groups. Secondary objectives include overall survival, pathological response, safety, and treatment-related adverse events. The results of this study may help optimize perioperative treatment strategies and improve outcomes for patients with locally advanced oral squamous cell carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 75 years at the time of enrollment.
ECOG Performance Status (PS) score of 0-1.
Primary lesion pathologically confirmed as oral squamous cell carcinoma (OSCC), including tumors of the anterior two-thirds of the tongue, gingiva, buccal mucosa, floor of the mouth, hard palate, or retromolar trigone.
Clinical stage III or IVA, defined as T1-2 with N1-2, or T3-4a and/or N0-2, according to the AJCC 8th edition OSCC TNM staging system.
Disqualifiers
Prior treatment targeting PD-1, PD-L1, PD-L2, or CTLA-4, or other therapies targeting T-cell costimulatory or immune checkpoint pathways.
Participation in another interventional clinical trial or use of an investigational drug or device within 4 weeks prior to the first dose.
History of radiotherapy involving the head, neck, or maxillofacial regions.
Use of traditional Chinese medicines or immunomodulatory agents with OSCC indications (e.g., thymosin, interferon, interleukin) within 2 weeks before first dosing; local therapy for pleural effusion control is permitted.
Trial design
Design model
Parallel
Treatments tested in this trial
Sintilimab plus nab-paclitaxel and platinum-based chemotherapy
DrugNeoadjuvant sintilimab combined with TP regimen followed by radical surgery and risk-stratified adjuvant therapy (low-risk: sintilimab monotherapy; high-risk: radiotherapy or concurrent chemoradiotherapy followed by sequential sintilimab).
Radical surgery combined with radiotherapy or chemoradiotherapy
Procedure/SurgeryParticipants undergo radical surgical resection as primary treatment, followed by postoperative radiotherapy or concurrent chemoradiotherapy according to pathological risk factors and standard clinical practice.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Experimental armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Event-Free Survival (EFS)
Event-free survival is defined as the time from randomization to the first occurrence of disease progression, local or distant recurrence, second primary malignancy, or death from any cause, whichever occurs first.
Time frame
2 yearsSecondary outcomes
1
overall survival（OS）
Overall survival (OS) was defined as the time from randomization to death from any cause.
Time frame
2 years and 5 years.2
pathological complete response（pCR）
Pathological complete response (pCR) is defined as the absence of residual viable tumor cells on microscopic examination in the resected primary tumor and lymph nodes, with all evaluated lymph nodes being negative. The pCR rate is calculated as the proportion of participants achieving pCR among all enrolled participants. The pCR rate is expressed as a percentage and its 95% confidence interval is estimated using the exact binomial distribution.
Time frame
At the time of definitive surgery3
Major Pathological Response (MPR)
Major pathological response (MPR) is defined as the presence of 10% or less residual viable tumor cells in the resected primary tumor specimen on microscopic examination after neoadjuvant treatment, regardless of lymph node status. The MPR rate is calculated as the proportion of participants achieving MPR among all enrolled participants. The MPR rate is expressed as a percentage and its 95% confidence interval is estimated using the exact binomial distribution.
Time frame
At the time of definitive surgery4
Treatment-related adverse events（TRAE）
Treatment-related adverse events (TRAEs) are defined as adverse events that are considered by the investigator to be possibly, probably, or definitely related to the study treatment, including sintilimab, chemotherapy, surgery, radiotherapy, or chemoradiotherapy. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 6.0. The incidence, severity, and type of TRAEs will be summarized and analyzed.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Qunxing Li,MD
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor institution
Source ClinicalTrials.gov