NCT07111455招募中不适用
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年7月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <＝
- •Signed informed consent form and voluntarily agreeing to participate in this study.
排除标准
- •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.
结局指标
主要结局
Objective Response Rate
时间窗: 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.
次要结局
- two-year overall survival rate(24 months)
- two-year progression-free survival rate(24 months)
研究者
研究点 (1)
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