Adjuvant Sintilimab Therapy for High-Risk Recurrent Esophageal Squamous Cell Carcinoma after Radical Resection: A Multicenter Randomized Controlled Clinical Trial Protocol

Background Esophageal cancer (EC) is among the most common malignant tumors of the human digestive tract. Most cases of esophageal cancer (EC) are diagnosed at an advanced stage. Due to the lack of effective adjuvant therapies following surgery for locally advanced esophageal squamous cell carcinoma, treatment options remain limited. With the promising preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma (ESCC), postoperative adjuvant immunotherapy for esophageal squamous cell carcinoma appears to be a feasible approach. The primary objective of this study was to evaluate the efficacy of postoperative adjuvant therapy with sintilimab in patients with esophageal squamous cell carcinoma (ESCC) who underwent radical resection following neoadjuvant chemoimmunotherapy. Methods All participants who meet the inclusion criteria will be enrolled after providing written informed consent.A total of 128 patients will be recruited for the study. Of these, 128 subjects will be randomly assigned to two treatment groups.Group A: Postoperative adjuvant sintilimab 200mg fixed dose Q3W, immunotherapy will be administered for a total of 1 year. Group B: Close observation. The primary endpoint is disease-free survival (DFS). The secondary endpoints are postoperative overall survival (OS); 1, 2, and 3-year postoperative OS rates; recurrent metastasis pattern (local recurrence or distant metastasis). Trial registration This study was registered with ClinicalTrials.gov (NCT06161909) on November 30, 2023.