The Mechanistic Study on the Influence of Gut Microbiota on Radiotherapy Sensitivity in Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Diameter of tumor
研究概览
简要总结
The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy.
详细描述
The study is expected to enroll 100 patients with locally advanced rectal cancer, including 50 patients in the radiotherapy-sensitive group and 50 in the radiotherapy-resistant group. Each participant will provide stool and blood samples before treatment for subsequent metagenomic and metabolomic sequencing analysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with late-stage rectal cancer (stages IIIB to IV), including those with postoperative recurrence re-staging or those intending to receive neoadjuvant treatment,
- •Pathological type is adenocarcinoma,
- •Have measurable lesions before radiotherapy or chemotherapy,
- •Age between 18 and 75 years,
- •A WHO Performance Status (PS) score of 0 to 2, capable of tolerating radiotherapy or chemotherapy,
- •An expected survival period of 6 months or more;
- •Able to understand the study and sign the informed consent form.
排除标准
- •Patients with severe complications or other malignant diseases.
- •Known severe allergic reactions to components of radiotherapy or chemotherapy.
- •Significant cardiac, hepatic, renal, or other vital organ dysfunction.
- •Pregnant or breastfeeding women.
- •Patients unable to comply with study requirements or affected by psychiatric or psychological diseases.
- •Participation in other clinical trials recently that could affect the assessment of this study's results.
结局指标
主要结局
Diameter of tumor
时间窗: 30 days
The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated
次要结局
- Change in Gut Microbiota Composition(30 days)
- Change in Plasma metabolites(30 days)
研究者
Jing-kun Liu
Principal Investigator
Xinjiang Medical University