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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    200
  • sponsor
    The Second Hospital of Shandong University
Updated on 28 January 2021

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.

Details
Condition Esophageal Diseases, Esophageal Disorders, Esophageal Cancer, Esophageal Cancer, Immunostimulant, Pharmaceutical Adjuvants, head and neck cancer, head and neck cancer, Immunotherapy, Esophageal Carcinoma, Gastroesophageal Cancer, Esophageal Disorders, immunomodulator, immunostimulants, immunomodulators, immunological adjuvant, immunologic adjuvant, esophagus cancer, oesophageal cancer, immunotherapies, cancer of the esophagus, oesophageal carcinoma
Treatment Immunotherapy, Chemotherapy Drugs, Cancer
Clinical Study IdentifierNCT04688801
SponsorThe Second Hospital of Shandong University
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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
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