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

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

Investigating the Relationship Between Oral Microbiome Alterations and Tumor Markers in Locally Advanced Oral Squamous Cell Carcinoma (LA-OSCC) After Neoadjuvant Chemoimmunotherapy: Implications for Therapeutic Efficacy, Chemoresistance, and Prognostic Assessment

Inclusion Criteria:

1. Oral squamous cell carcinoma (OSCC) diagnosed as locally advanced (T3N0M0, T1-3N1M0, T4aN0-2M0, T1-4aN3M0, or T4bN0-3M0) according to AJCC staging criteria.
2. Their age ranged from 18 to 80 years;regardless of gender.
3. Absence of prior head and neck radiation therapy or chemotherapy.
4. 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.
5. 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.
6. Adequate renal function：estimated glomerular filtration rate (eGFR) greater than 45 mL/min per 1.73 m².
7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI.
8. PS score <＝2.
9. Signed informed consent form and voluntarily agreeing to participate in this study.

Exclusion Criteria:

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