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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Chemotherapy± Radiotherapy after surgery
Chemotherapy + Immuonotherapy ± Radiotherapy after surgery
The Second Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGdisease free survival rate
disease free survival after surgery
Time frame: 5 years after surgery
overall survival rate
overall survival after surgery
Time frame: 5 years after surgery
Rate of adverse events
Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)
Time frame: within 6 months
Quality of Life (KPS or PS or QOL or EORTC QLQ C30)
Quality of Life (KPS or PS or QOL or EORTC QLQ C30)after therapy
Time frame: 5 years after therapy
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