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

Recruitingn/aAges 18 Years - 80 YearsAllZhujiang Hospital
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Department of Stomatology, Zhujiang Hospital, Southern Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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