Mouth bacteria changes after chemoimmunotherapy for locally advanced oral cancer

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

We will test whether changes in mouth bacteria after neoadjuvant chemoimmunotherapy are linked to tumor markers, treatment resistance, and outcomes in adults with locally advanced oral squamous cell carcinoma.

Quick facts

• Study type: Observational
• Enrollment: 32 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07111455 on ClinicalTrials.gov

What this trial studies

This prospective observational cohort will enroll adults (18–80) with locally advanced oral squamous cell carcinoma who have not had prior head and neck chemotherapy or radiation. Oral microbiome samples and clinical specimens will be collected before and after planned neoadjuvant chemoimmunotherapy and analyzed using sequencing and biomarker assays. Researchers will correlate microbiome changes with tumor markers, measures of chemoresistance, and clinical outcomes through the surgery and follow-up period. No experimental treatments are assigned; the study aims to identify microbial signatures associated with response and prognosis to inform future trials.

Who should consider this trial

Good fit: Adults aged 18–80 with locally advanced OSCC by AJCC criteria, no prior head/neck chemo or radiation, adequate organ function, ECOG/PS ≤2, and who consent to sampling and follow-up are ideal candidates.

Not a fit: Patients with prior head or neck chemo/radiation, stages outside the specified LA‑OSCC criteria, pregnancy, severe organ dysfunction (for example eGFR ≤45 mL/min/1.73 m²), PS >2, or those unwilling to consent are unlikely to be eligible or to benefit from the study.

Why it matters

Potential benefit: If successful, the findings could help predict who will benefit from neoadjuvant chemoimmunotherapy and guide more personalized treatment decisions.

How similar studies have performed: Previous studies in other cancers have linked the microbiome to immunotherapy response, but applying oral microbiome profiling to predict chemoimmunotherapy outcomes in LA‑OSCC remains relatively novel.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Department of Stomatology, Zhujiang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xiaozhi LV

Conditions Locally Advanced Oral Squamous Cell Carcinoma; Oral Microbiome; Neoadjuvant Chemoimmunotherapy