Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy

Inclusion criteria

• Oral squamous cell carcinoma (OSCC) diagnosed as locally advanced (T3N0M0, T1-3N1M0, T4aN0-2M0, T1-4aN3M0, or T4bN0-3M0) according to AJCC staging criteria.
• Their age ranged from 18 to 80 years;regardless of gender.
• Absence of prior head and neck radiation therapy or chemotherapy.
• Adequate blood function: white blood cell count (WBC) >＝3.5×10^9/L, platelet count (PLT) >＝75×10^9/L：Hemoglobin concentration (HGB) >＝90g/L.
• Adequate liver function： total bilirubin (TBIL) <＝ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <＝2.5 times the upper limit of normal.
• Adequate renal function：estimated glomerular filtration rate (eGFR) greater than 45 mL/min per 1.73 m².
• The heart, brain, lung and other vital organs function and general condition can tolerate NACI.
• PS score <＝2.
• Signed informed consent form and voluntarily agreeing to participate in this study.

Exclusion criteria

• Pregnancy or lactation (for female participants).
• Patients with a history of epilepsy or psychiatric disorders that were not well-controlled.
• Patients with severe allergic diathesis or suspected or confirmed alcohol or drug addiction.
• Patients who had taken antibiotics within 7 days before enrollment.