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

RecruitingNAAges 25 Years - 80 YearsAllThe Second Hospital of Shandong University
NCT04688801 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Chemotherapy Drugs, Cancer
  • Immunotherapy
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Where

1 site
The Second Hospital of Shandong University
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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