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

Exclusion Criteria

• •1. Known distant metastases of the tumor.
• •2. History of tongue squamous cell carcinoma or other malignant tumors of the tongue within the past 5 years.
• •3. 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.
• •4. Previous allogeneic tissue or organ transplantation.
• •5. Unresolved ≥Grade 2 (CTCAE v5.0) toxicities from prior anticancer treatments, except alopecia.
• •6. Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, NYHA class ≥II heart disease within 3 months prior to enrollment).
• •7. Active serious clinical infections (\>Grade 2 NCI-CTCAE v5.0).
• •8. 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.
• •9. 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
• •10. Pregnant women; breastfeeding women must discontinue breastfeeding to participate.
• •11. History of substance abuse or psychiatric disorders that would interfere with study participation.
• •12. Participation in another clinical trial within 30 days prior to enrollment.