Home › Trials › NCT07111455
Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Mouth bacteria changes after chemoimmunotherapy for locally advanced oral cancer

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

Run by Zhujiang Hospital · NCT07111455 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment32 (estimated)
SponsorZhujiang Hospital
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedJuly 22, 2025
Main results expectedDecember 30, 2026
Study endsJuly 30, 2027
Registry record updatedSeptember 23, 2025
Trial IDNCT07111455 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Locally Advanced Oral Squamous Cell Carcinoma 2Zhujiang Hospital 44
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.