About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with locally advanced oral squamous cell carcinoma (OSCC) attending the Department of Stomatology, Zhujiang Hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
two-year overall survival rate
The proportion of patients surviving ≥2 years post-treatment
two-year progression-free survival rate
The proportion of patients who remain alive and progression-free for 2 years after treatment
Sponsors and contacts
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