Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
NCT ID: NCT07111455
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
32 participants
OBSERVATIONAL
2025-07-22
2027-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exposed Group
Participants were planned to receive 2 cycles of intravenous neoad- juvant Tislelizumab (200 mg) every 3 weeks,and Paclitaxel 135-175mg/m² ,Cisplatin 80-120mg/m² or Carboplatin 0.3-0.4g/m² through intravenous infusion each 3-week cycle for 2 cycles.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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.
18 Years
80 Years
ALL
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Locations
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Department of Stomatology, Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-KY-189
Identifier Type: -
Identifier Source: org_study_id
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