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.
Parallel
Tislelizumab
Drug1. Option 1: adjuvant chemoradioimmunotherapy in the following sequence: * Cycle 1: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for one cycle * Cycle 2: Concurrent radiotherapy (25 fractions of 1.8 Gy each, with 5 fractions per week) with Tislelizumab 200 mg iv D1, D22, Paclitaxel 50 mg/m2 iv D1, 8, 15, 22, 29, and Carboplatin AUC 2 mg/mL/min D1, 8, 15, 22, 29 * Cycle 3: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for 1 cycle * Cycles 4-9: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles 2. Option 2: adjuvant chemoimmunotherapy in the following sequence: * Cycles 1-4: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for four cycles * Cycles 5-10: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles
Recurrence-free survival as assessed by the investigator
Every 12weeks during the first two years after randomization then every 24weeks
Overall survival
Every 12weeks during the first two years after randomization then every 24weeks
Distant metastasis-free survival
Every 12weeks during the first two years after randomization then every 24weeks
Locoregional Recurrence-free survival
Every 12weeks during the first two years after randomization then every 24weeks
Pattern of first recurrence
Every 12weeks during the first two years after randomization then every 24weeks
• Lead time between ctDNA re-emergence and radiologic recurrence
• To evaluate the lead time between ctDNA re-emergence and radiologic recurrence
• Association between ctDNA dynamics and patterns of recurrence (locoregional vs. distant)
• To evaluate the association between ctDNA dynamics and patterns of recurrence (locoregional vs. distant)
• PD-L1 expression by IHC as a predictive biomarker for treatment efficacy
• To evaluate the correlation between PD-L1 expression levels (measured by immunohistochemistry \[IHC\]) and the efficacy of tislelizumab-based adjuvant therapy versus surveillance alone
• Status of exploratory biomarkers including but not limited to tumor mutation burden, and immune-related gene expression profiling in archival tumor tissues and blood (or blood derivatives) obtained before, during, or after study treatment and surveilla
• To assess potential biomarkers associated with treatment efficacy, safety, pharmacodynamic activity, and the mechanism of action, as well as patient prognosis, by analyzing biomarker measures within the tumor microenvironment and periphery samples (e.g., cfDNA, blood, serum, plasma, and PBMCs) in relation to clinical outcomes
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