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Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy | Clinical Trials | Clareo Health

RECRUITING

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

NCT07111455•Zhujiang Hospital

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Department of Stomatology, Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Key Dates

Start Date

July 22, 2025

Primary Completion Date

December 30, 2026

Completion Date

July 30, 2027

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Oral Squamous Cell Carcinoma

Contacts

Xiaozhi LV

CONTACT

+86-020-62782092 lxzsurgeon@126.com

Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma

NCT07371611

Locally Advanced Oral Squamous Cell CarcinomaOral Squamous Cell Carcinoma (OSCC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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