Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122701
Enrollment
Unknown
Registered
2026-04-16
Start date
2025-07-22
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Oral Squamous Cell Carcinoma

Interventions

Case series:NA

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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:urinary white blood cells < 10, red blood cells < 10, cast count < 5 per high-power field, serum creatinine in the range of 186-351 mmol /L, and creatinine (CRE) <= the upper limit of normal. 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

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.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate,ORR;

Secondary

MeasureTime frame
two-year progression-free survival rate;two-year overall survival rate;

Countries

China

Contacts

Public ContactLyu Xiaozhi

Zhujiang Hospital of Southern Medical University

lxzsurgeon@126.com+86 20 62782092

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026