Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma

Exclusion Criteria

• •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.
• •History of active autoimmune disease within the past 2 years requiring systemic therapy (e.g., corticosteroids or immunosuppressants). Exceptions include:
• •1\. Hypothyroidism controlled with thyroid hormone replacement therapy.
• •2\. Diabetes mellitus controlled with insulin.
• •3\. Adrenal or pituitary insufficiency treated with physiologic doses of corticosteroids.
• •Use of immunosuppressive agents:
• •1\. Systemic corticosteroid therapy within 1 week prior to the first dose is prohibited.
• •2\. Use of other immunosuppressive drugs is prohibited.
• •3\. Intranasal, inhaled, or topical corticosteroids are permitted.
• •4\. Physiologic doses of corticosteroids (e.g., prednisone ≤10 mg/day or equivalent) are permitted.
• •Prior systemic antitumor therapy, except patients who have had ≥12 months of treatment-free interval between the last chemotherapy and initiation of neoadjuvant therapy.
• •Previous allogeneic organ or hematopoietic stem cell transplantation (excluding corneal transplantation).
• •Known hypersensitivity to sintilimab, carboplatin, cisplatin, nab-paclitaxel, or any of their excipients.
• •Failure to recover to baseline or ≤ grade 1 (except fatigue or alopecia) from adverse events or complications of prior interventions before enrollment.
• •Known human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive).
• •Untreated active hepatitis B infection (HBsAg positive with HBV-DNA above the ULN). Subjects meeting the following criteria may be enrolled:
• •1\. HBV viral load \<1000 copies/mL (200 IU/mL) and receiving antiviral therapy during the study to prevent reactivation.
• •2\. Subjects who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV-DNA(-) do not require prophylactic antiviral therapy but must be closely monitored for viral reactivation.
• •Active hepatitis C infection (HCV antibody positive with HCV-RNA above the lower limit of detection).
• •Receipt of a live vaccine within 30 days prior to the first dose (inactivated vaccines, such as inactivated influenza vaccine, are permitted; intranasal live vaccines are not allowed).
• •Pregnant or breastfeeding women.
• •Presence of severe or uncontrolled systemic diseases, including but not limited to:
• •1\. Cardiac disorders: severe arrhythmias (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or persistent atrial fibrillation), unstable angina, or congestive heart failure (NYHA class ≥ II).
• •2\. Vascular disorders: history of unstable angina, myocardial infarction, transient ischemic attack, or stroke within 6 months before enrollment.
• •3\. Poorly controlled hypertension (systolic BP \>140 mmHg or diastolic BP \>90 mmHg).
• •4\. Pulmonary disorders: noninfectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose, or active interstitial lung disease.
• •5\. Infectious diseases: active infections requiring systemic treatment, or severe uncontrolled infections.
• •6\. Active pulmonary tuberculosis.
• •7\. Gastrointestinal disorders: clinically active diverticulitis, intra-abdominal abscess, or intestinal obstruction.
• •8\. Hepatic disorders: liver cirrhosis, decompensated liver disease, or acute/chronic active hepatitis.
• •9\. Poorly controlled diabetes mellitus: fasting blood glucose (FBG) \>10 mmol/L.
• •10\. Renal dysfunction: urine protein ≥++ on urinalysis and 24-hour urinary protein \>1.0 g.
• •11\. Psychiatric disorders: severe mental illness that may affect treatment compliance.
• •Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.