This study was a multicenter, randomized, phase 3 trial to determine whether adjuvant chemotherapy including tisleliizumab improves recurrence-free survival compared to follow-up alone without chemotherapy in patients with curatively resected esophageal squamous cell carcinoma.
1. Be willing and able to provide written informed consent. 2. Be ≥19 years of age on the day of signing the informed consent form. 3. Have ECOG performance status of 0 or 1 (Appendix 1). 4. Have a histologically confirmed diagnosis of squamous cell carcinoma of the esophagus
Patients with tumors of mixed histology (i.e., squamous and non-squamous) are eligible if the predominant histological component is squamous, except when small cell or neuroendocrine elements are present.
For patients who underwent upfront surgery, surgical tissue is preferred.
For those who received neoadjuvant therapy followed by surgery, pre-treatment biopsy tissue is required. If pre-treatment biopsy tissue is unavailable or inadequate, submission of surgical specimens may be permitted following approval by the Study Sponsor.
1. Documented recurrence of esophageal cancer before randomization following curative resection.
Replacement therapy (e.g., thyroxine for autoimmune-related hypothyroidism, insulin for type 1 diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is permitted if there is no active autoimmune disease.
A short course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergens) is permitted.