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Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer
Sponsor: The Second Hospital of Shandong University
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
25 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2020-07-01
Completion Date
2027-12-31
Last Updated
2022-11-16
Healthy Volunteers
No
Interventions
Chemotherapy Drugs, Cancer
Chemotherapy± Radiotherapy after surgery
Immunotherapy
Chemotherapy + Immuonotherapy ± Radiotherapy after surgery
Locations (1)
The Second Hospital of Shandong University
Jinan, Shandong, China