Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer
Recruiting now · Not applicable
Conditions studied: Esophageal Cancer, Gastroesophageal Cancer, Immunotherapy, Adjuvant
In brief
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.
Key facts
- Study ID
- NCT04688801
- Run by
- The Second Hospital of Shandong University
- People needed
- 200
- Starts
- 2020-07-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2022-11-16
Who can join
Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Second Hospital of Shandong University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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