Abstract 1435TiP
Background
Esophageal squamous cell carcinoma (ESCC) patients with nodal disease (ypN+) after conventional trimodality are at high risk of recurrence. Furthermore, chemoradiotherapy is not the standard of care for localized ESCC patients in many parts of the world, where neoadjuvant chemotherapy is preferred. Immunotherapy, as an adjuvant approach, has been demonstrated effective and changed the standard of care. Adjuvant immunotherapy following perioperative chemotherapy has not been investigated as a treatment option in the Asian population. Key questions, such as the benefit of chemoimmunotherapy in these patients, need to be explored.
Trial design
AIRES, a multicenter, open-label, randomized phase III trial, aims to evaluate the efficacy and safety of adjuvant chemotherapy combined with immune checkpoint inhibitor versus immune checkpoint inhibitor alone in high risk [(y)pN+] radically resected ESCC patients. Key inclusion criteria include (y)pN+ following neoadjuvant chemoradiotherapy or chemotherapy plus surgery or upfront surgery with R0 resection. Eligible patients (n=220) will be randomized (1:1) to receive adjuvant chemotherapy (cisplatin-based doublets every 3 weeks for two cycles) followed by tislelizumab 200 mg intravenously every 3 weeks for 1 year or tislelizumab 200 mg intravenously every 3 weeks for 1 year. The primary endpoint is disease-free survival. The secondary endpoints include overall survival, safety and quality of life. The translational analyses are also evaluated. Pre-treatment biopsies, post-resection specimens, serial liquid biopsy, and gut microbiota samples on treatment will be collected to explore the biomarkers’ predictive value on immune checkpoint inhibitor efficacy and safety. Recruitment begins in early May 2021 and will be completed in 18 months. This study has been registered with the number of ChiCTR2100045651.
Clinical trial identification
ChiCTR2100045651.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
BeiGene (Beijing) Co.,Ltd.
Disclosure
All authors have declared no conflicts of interest.