Intestinal and Oral Microbiota Signatures of Clinical Response and Adverse Events in HCC Treated With Systemic Therapies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Long-term outcomes after treatment
研究概览
简要总结
By tracking the short-term and long-term results of HCC patients treated with systemic therapies,the difference of microbiota between responded patients and non-responded patients was analyzed, and the correlation between gut and oral microbiota and short-term and long-term results was explored, so as to improve people's awareness of microbiota and pay attention to its prevention and treatment.
详细描述
The investigators consecutively admit patients the questionnaire and collect the fecal. And by tracking the short-term and long-term outcomes of HCC patients treated with systemic therapies,the difference of gut microbiota between responded patients and non-responded patients is analyzed, and the correlation between gut and oral microbiota and short-term and long-term results is explored.Adverse events (AE) are recorded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 4.0).Tumor response is mainly evaluated by experienced hepatologists using radiological method within 4-12 weeks after treatments according to the RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST).Overall survival (OS) and Progression-free survival (PFS) are recorded.
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
- •clinically or pathologically diagnosed HCC
- •didn't receive prior anti-tumor treatments
- •didn't receive prior antibiotics
- •Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1
- •Child-Pugh score of ≤7
- •complete clinical and follow-up information.
排除标准
- •combined with other malignancies
- •receive surgical treatment
- •lost follow-up
- •Child-Pugh score of>7
- •uncompleted clinical and follow-up information
- •overall survival less than 1 month
- •receive prior antibiotics
结局指标
主要结局
Long-term outcomes after treatment
时间窗: 1 year
Overall survival and progression-free survival
Post-treatment adverse events
时间窗: 3 months
Post-treatment complications are recorded
次要结局
- Objective response rate(3 months)
研究者
Gang Chen, MD
Clinical Professor, Principal Investigator
First Affiliated Hospital of Wenzhou Medical University