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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Department of Stomatology, Zhujiang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Xiaozhi LV
lxzsurgeon@126.com
+86-020-62782092
Time Frame
Start Date: 2025-07-22
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 32
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov