Locally Advanced Oral Squamous Cell Carcinoma
Conditions
Keywords
Oral Microbiome, Neoadjuvant Chemoimmunotherapy
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
Interventions
None listed
Sponsors
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| two-year overall survival rate | 24 months | The proportion of patients surviving ≥2 years post-treatment |
| two-year progression-free survival rate | 24 months | The proportion of patients who remain alive and progression-free for 2 years after treatment |
Countries
China
Contacts
Primary ContactXiaozhi LV
Outcome results
None listed