Actively Recruiting
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
Led by Zhujiang Hospital · Updated on 2025-09-23
32
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with locally advanced oral squamous cell carcinoma (stages T3N0M0, T1-3N1M0, T4aN0-2M0, T1-4aN3M0, or T4bN0-3M0) according to AJCC criteria
- Aged between 18 and 80 years, any gender
- No prior head and neck radiation therapy or chemotherapy
- Adequate blood function: white blood cell count ≥3.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥90 g/L
- Adequate liver function: total bilirubin ≤ upper limit of normal, AST and ALT ≤2.5 times upper limit of normal
- Adequate kidney function: estimated glomerular filtration rate >45 mL/min/1.73 m²
- Heart, brain, lung, and other vital organs functioning well enough to tolerate neoadjuvant chemoimmunotherapy
- Performance status score ≤2
- Signed informed consent and voluntarily agree to participate
You will not qualify if you...
- Pregnancy or breastfeeding (for female participants)
- History of epilepsy or uncontrolled psychiatric disorders
- Severe allergies or suspected/confirmed alcohol or drug addiction
- Use of antibiotics within 7 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Stomatology, Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
Xiaozhi LV
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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