About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Chemotherapy Drugs, Cancer
DrugChemotherapy± Radiotherapy after surgery
Immunotherapy
DrugChemotherapy + Immuonotherapy ± Radiotherapy after surgery
Treatment groups
Trial outcomes
Primary outcomes
disease free survival rate
disease free survival after surgery
overall survival rate
overall survival after surgery
Secondary outcomes
Rate of adverse events
Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)
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
Sponsors and contacts
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