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

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

Recruiting
25-80 years
All
Phase N/A

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Overview

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

Inclusion Criteria:

        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.
        Exclusion Criteria:
        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.

Study details
    Esophageal Cancer
    Gastroesophageal Cancer
    Immunotherapy
    Adjuvant

NCT04688801

The Second Hospital of Shandong University

25 January 2024

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