跳至主要内容
临床试验/NCT04688801
NCT04688801招募中不适用

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)

The Second Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验