Study of Sintilimab as Additional Treatment After Surgery for Node-Positive Esophageal Squamous Cell Carcinoma Without Prior Therapy

What this Trial Is About

Researchers are studying the use of sintilimab as an additional treatment for people with node-positive esophageal squamous cell carcinoma who have undergone radical surgery without prior neoadjuvant therapy. The goal is to assess how well sintilimab works and how safe it is when given after surgery. This is a Phase 2 clinical trial sponsored by Zhejiang Cancer Hospital focusing on this specific type of esophageal cancer. Participants in the study will receive sintilimab at a dose of 200 mg given once on day 1, repeated every 21 days. This adjuvant therapy is intended to be administered after the surgical removal of the cancer. The study does not include a placebo or comparison group, and the treatment will continue according to this schedule. Throughout the study, participants will be monitored regularly, with disease-free survival being tracked for up to 36 months as the primary outcome. Overall survival will also be assessed for up to 60 months. Evaluations will include physical and imaging examinations such as CT or MRI scans of the neck, chest, and abdomen, as well as laboratory tests to check blood counts and organ function. Safety and adherence to treatment will be carefully observed during follow-up visits over the study period.

A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC