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

What this Trial Is About

Researchers are investigating whether adding immunotherapy to chemotherapy after surgery can improve outcomes for patients with esophageal or esophageal-gastric junction cancer who are at high risk of recurrence. This study focuses on patients who have undergone surgery, with or without prior neoadjuvant therapy, and are identified as high risk due to poor response to neoadjuvant treatment, incomplete tumor removal, or lymph node metastasis. The trial aims to evaluate disease-free survival as the primary outcome, along with overall survival, safety, toxicity, and quality of life. The study compares two groups of high-risk patients after surgery: one receiving chemotherapy with or without radiotherapy, and the other receiving chemotherapy combined with immunotherapy, with or without radiotherapy. Treatment is given as adjuvant therapy following surgery and possible neoadjuvant therapy. Patients are randomly assigned to one of these treatment groups in a double-blinded fashion. Participants will be followed for up to five years after surgery, with assessments focused on disease-free survival and overall survival rates. Safety is monitored by recording adverse events within six months, and quality of life is evaluated using standard performance and quality of life scales. The study involves regular check-ups and evaluations to track treatment effects and patient well-being throughout the follow-up period.

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