Mouth bacteria may predict cancer treatment success
NCT ID NCT07111455
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looks at how the community of bacteria in the mouth changes in 32 people with advanced oral cancer after they receive a combination of chemotherapy and immunotherapy. Researchers want to see if these bacterial shifts relate to how well the tumor shrinks and to long-term survival. The goal is to find clues that could one day help personalize treatment for oral cancer patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemoimmunotherapy (chemotherapy plus immunotherapy)
- What this could lead to
- If successful, this could help doctors predict which oral cancer patients will respond best to chemoimmunotherapy, potentially guiding more personalized treatment.
- What could go wrong
- This is a small, early observational study with only 32 participants, so findings may not apply to all patients. It is designed to gather knowledge, not to test a new treatment directly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with locally advanced oral squamous cell carcinoma (OSCC) attending the Department of Stomatology, Zhujiang Hospital.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Stomatology, Zhujiang Hospital, Southern Medical University
RECRUITINGGuangzhou, Guangdong, China
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