Recruiting NCT07111455
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Locally Advanced Oral Squamous Cell Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Objective Response Rate [Time frame: 8 weeks]
Secondary outcome measures (2)
- two-year overall survival rate [Time frame: 24 months]
- two-year progression-free survival rate [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Stomatology, Zhujiang Hospital, Southern Medical University — Guangzhou
Identifiers
NCT: NCT07111455 · 2025-KY-189