Clinical Trial

Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer

Recruiting
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Record status
This record was last updated November 16, 2022 (before its estimated December 31, 2023 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-12-25.
Trial Details
NCT Number NCT04688801
Lead Sponsor The Second Hospital of Shandong University
Conditions Esophageal Cancer, Gastroesophageal Cancer, Immunotherapy, Adjuvant
Enrollment 200 participants
Start Date 2020-07-01
Primary Completion 2023-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2022-11-16