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

NCT07111455 | Recruiting DMC

• 1 other identifier: 2025-KY-189
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Locally Advanced Oral Squamous Cell Carcinoma

Keywords

Oral Microbiome; Neoadjuvant Chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, it is defined as the proportion of patients who achieved Complete Response (CR) or Partial Response (PR).Complete Response (CR) was defined as disappearance of all target lesions. Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions.

  8 weeks

Secondary Outcomes (2)

• two-year overall survival rate

  24 months

• two-year progression-free survival rate

  24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced oral squamous cell carcinoma (OSCC) attending the Department of Stomatology, Zhujiang Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Department of Stomatology, Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

16S rRNA Swab Sample from Oral Tumor;Saliva

Central Study Contacts

Xiaozhi LV

CONTACT

+86-020-62782092; lxzsurgeon@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)