Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer With or Without Preoperative Chemotherapy With High Risk for Recurrence (N+ and/ or R1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- disease free survival rate
研究概览
简要总结
Surgery with or without neoadjuvant therapy is usually used as the treatment for resectable esophageal cancer or esophageal- gastric junction cancer. Patients who have a poor response to neoadjuvant therapy and have an incomplete (R1) resection or have metastatic lymph nodes in the resection specimen (N+) are especially at risk of recurrence, to continue with the chemotherapy± radiotherapy is often used in these cases. However, the overall survival is still poor. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival. The primary endpoint ofthe study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven esophageal or EG-junction carcinoma (Siewert I-II). The heart and lung function can tolerate surgery. The cancer is resectable and incurable therapy will be perfomed.
排除标准
- •EG-junction carcinoma (Siewert III). M1 stage according to the current (8th) version of TNMclassification system. The heart and lung function can't tolerate surgery. R2 Resection Status.
研究组 & 干预措施
Chemotherapy± Radiotherapy Group
Chemotherapy± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.
干预措施: Chemotherapy Drugs, Cancer (Drug)
Chemotherapy + Immunotherapy ± Radiotherapy Group
Chemotherapy + Immunotherapy ± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.
干预措施: Immunotherapy (Drug)
结局指标
主要结局
disease free survival rate
时间窗: 5 years after surgery
disease free survival after surgery
overall survival rate
时间窗: 5 years after surgery
overall survival after surgery
次要结局
- Rate of adverse events(within 6 months)
- Quality of Life (KPS or PS or QOL or EORTC QLQ C30)(5 years after therapy)
