RecruitingNCT07111455
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
Sponsor
Zhujiang Hospital
Enrollment
32 participants
Start Date
Jul 22, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria9
- Oral squamous cell carcinoma (OSCC) diagnosed as locally advanced (T3N0M0, T1-3N1M0, T4aN0-2M0, T1-4aN3M0, or T4bN0-3M0) according to AJCC staging criteria.
- Their age ranged from 18 to 80 years;regardless of gender.
- Absence of prior head and neck radiation therapy or chemotherapy.
- 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.
- 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.
- Adequate renal function：estimated glomerular filtration rate (eGFR) greater than 45 mL/min per 1.73 m².
- The heart, brain, lung and other vital organs function and general condition can tolerate NACI.
- PS score \<＝2.
- Signed informed consent form and voluntarily agreeing to participate in this study.
Exclusion Criteria4
- Pregnancy or lactation (for female participants).
- Patients with a history of epilepsy or psychiatric disorders that were not well-controlled.
- Patients with severe allergic diathesis or suspected or confirmed alcohol or drug addiction.
- Patients who had taken antibiotics within 7 days before enrollment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07111455