Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
Esophageal cancer accounts for more than half of the world, seriously affecting people's health in China. 95% patients are squamous cell carcinoma. Surgery is the preferred treatment for early and middle stage esophageal cancer, but patients with clinical stage T4b or other surgical contraindications have no surgical opportunity. In recent years, radical chemoradiotherapy has played a key role in the treatment of local advanced esophageal cancer with some poor predicting biomarkers. Oral bacteria may play a pathogenic role in cancer and other chronic diseases by producing chemical carcinogens and inflammatory factors through direct metabolism. A large number of studies have also suggested that tooth loss and poor oral hygiene are closely related to upper digestive tract cancer, indicating the possible role of oral microorganisms in the occurrence and development of upper digestive tract cancer, and saliva is the main source of oral flora colonization. Therefore, it is worth further research to explore the interaction between microbial metabolism imbalance and radiotherapy in patients with esophageal cancer. In summary, we intend to conduct a prospective cohort study to explore the role of salivary microbes in radiotherapy in patients with initially inoperable patients with local advanced esophageal cancer.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-85 years old;
- •Eastern Cooperative Oncology Group (ECOG) 0-2;
- •Esophageal squamous cell carcinoma;
- •cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
- •initial unresectable at initial diagnosis confirmed by thoracic surgeons;
- •Treatment naive;
- •No contraindications for adjuvant chemoradiotherapy;
- •Signature of inform consent.
排除标准
- •• younger than 18 years old or older than 85 years old;
- •Esophageal adenocarcinoma, small-cell cancer and other pathological types;
- •cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;
- •Resectable at initial diagnosis confirmed by thoracic surgeons;
- •Previous treatment of chemotherapy, radiotherapy, and other treatment;
- •Contraindications for chemoradiotherapy;
- •No signature of inform consent.
结局指标
主要结局
pCR
时间窗: 1 month post treatment
次要结局
- EFS(1 to 3 years)
- the surgical conversion rate(1month post treatment)
研究者
Dong Qian
dr
Anhui Provincial Hospital
