NCT07111455 Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
| NCT ID | NCT07111455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Locally Advanced Oral Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 32 participants in total. It began in 2025-07-22 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07111455 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Locally Advanced Oral Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111455 currently recruiting?
Yes, NCT07111455 is actively recruiting participants. Contact the research team at lxzsurgeon@126.com for enrollment information.
Where is the NCT07111455 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07111455 clinical trial?
NCT07111455 is sponsored by Zhujiang Hospital. The trial plans to enroll 32 participants.