Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer

Inclusion criteria

• Age 18-75 years, male or female.
• Histologically or cytologically confirmed primary tongue squamous cell carcinoma (cT3 or cT4).
• Patients scheduled to receive 2 cycles of preoperative neoadjuvant chemoimmunotherapy with tirelizumab, cisplatin, and albumin-bound paclitaxel.
• Patients planned to undergo surgical resection of tongue cancer following neoadjuvant therapy.
• Voluntary participation with signed informed consent, good compliance, and willingness to follow study procedures.

Exclusion criteria

• Known distant metastases of the tumor.
• History of tongue squamous cell carcinoma or other malignant tumors of the tongue within the past 5 years.
• Active infection requiring systemic therapy; non-infectious pneumonia or interstitial lung disease requiring steroid therapy, or current pneumonia/interstitial lung disease; known hepatitis B infection (HBsAg positive) or active hepatitis C infection (detectable HCV RNA); known HIV infection.
• Previous allogeneic tissue or organ transplantation.
• Unresolved ≥Grade 2 (CTCAE v5.0) toxicities from prior anticancer treatments, except alopecia.
• Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, NYHA class ≥II heart disease within 3 months prior to enrollment).
• Active serious clinical infections (>Grade 2 NCI-CTCAE v5.0).
• Uncontrolled hypertension (treated systolic BP >150 mmHg and/or diastolic BP >90 mmHg) or clinically significant cardiovascular disease, including recent cerebrovascular accident or myocardial infarction (≤6 months), unstable angina, NYHA class ≥II congestive heart failure, or severe arrhythmia not controlled by medication that could affect study treatment.
• Laboratory abnormalities:

Hematology: WBC <3,000/mm³, Hb <8 g/dL, platelets <80,000/mm³ Liver function: ALT/AST >3× upper limit of normal, bilirubin >1.5× ULN Renal function: serum creatinine >1.5× ULN, renal failure requiring dialysis Diabetes: poorly controlled (FBG >10 mmol/L) Proteinuria: urine protein ≥++ and 24-hour urine protein >1.0 g

• Pregnant women; breastfeeding women must discontinue breastfeeding to participate.
• History of substance abuse or psychiatric disorders that would interfere with study participation.
• Participation in another clinical trial within 30 days prior to enrollment.