Clinical trial · Observational
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
NCT07111455CI-TRIAL-00095622recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Exposed Group
- description
- 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.
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 8 weeks
- description
- 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 outcomes (2)
- measure
- two-year overall survival rate
- timeFrame
- 24 months
- description
- The proportion of patients surviving ≥2 years post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.