RecruitingNot ApplicableNCT04688801

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

Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer With or Without Preoperative Chemotherapy With High Risk for Recurrence (N+ and/ or R1)

Sponsor

The Second Hospital of Shandong University

Enrollment

200 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Immunotherapy Gastroesophageal Cancer Adjuvant

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.

Eligibility

Min Age: 25 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding immunotherapy and chemotherapy after surgery for esophageal or gastroesophageal junction (where the food pipe meets the stomach) cancer improves survival compared to observation alone. **You may be eligible if...** - You have been diagnosed with esophageal or gastroesophageal junction cancer (Siewert type I or II) confirmed by biopsy - Your cancer can be surgically removed with intent to cure - Your heart and lung function are strong enough to tolerate surgery **You may NOT be eligible if...** - Your cancer is classified as Siewert type III (a lower junction cancer near the stomach) - Your cancer has spread to distant organs (stage M1) - Your heart or lung function cannot support surgery - Your surgery resulted in incomplete removal of the tumor (R2 resection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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