Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07111455

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Stomatology, Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Actively Recruiting

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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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