Anhui Provincial Hospita
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Rate of adverse events
研究概览
简要总结
Chemoradiotherapy has been a standard modality for inoperable locally advance esophageal carcinoma. The goal of this randomized control study is to compare the feasibility, and survival benefits of whole-course immunonutrition combined with chemoradiotherapy±ICIs for local advanced patients with inoperable esophageal squamous cell carcinoma. The main questions it aims to answer are: • If the feasibility and safety of whole-course immunonutrition combined with chemoradiotherapy±ICIs is better. • If the survival benefits (1, 2 and 3-years progression free survival) of whole-course immunonutrition combined with chemoradiotherapy±ICIs is longer. The Experimental group will receive a combination immunonutrition of omega-3 fatty acids, and glutamine, whereas the control group will receive standard formula.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
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
Rate of adverse events
时间窗: 1 month post treatment
Rate of adverse events (CTCAE V4.0)
Disease Control Rate
时间窗: 1 month post treatment
Disease Control Rate
次要结局
- 1-, 2-, 3-year Progression-free survival rate (PFS).(1 to 3 years)