Glossary of Abbreviations:AEs (adverse events), CT (computed tomography), ESCC (esophageal squamous cell carcinoma), ICI (immune checkpoint inhibitor), nCRT (neoadjuvant chemoradiotherapy), OS (overall survival), pCR (pathologic complete response), PD-1 (programmed cell death protein 1), PD-L1 (programmed cell death ligand 1), PET-CT (positron emission tomography-computed tomography), PPCT (preoperative pembrolizumab combined with chemoradiotherapy)
Publication stageIn Press Journal Pre-Proof
Conflict of Interest Statement: Hecheng Li is currently receiving a CSCO-MSD Cancer Research Fund. For the remaining authors none were declared.
Funding Statement: This study was supported by the CSCO-MSD Cancer Research Fund (Y-MSD2020-0279).
Clinical Trial Registry Number: NCT04435197.
Institutional Review Board Approval: This study has been approved by the ethics committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine on May 26, 2020 (approval number, 2020-109).
Central Picture Legend
Flow chart of the PALACE-2 trial.
This multicenter single-arm PALACE-2 trial will evaluate the efficacy and safety of preoperative pembrolizumab with chemoradiotherapy for locally advanced esophageal squamous cell carcinoma.
Preoperative immunotherapy with concurrent chemoradiotherapy was preliminarily demonstrated to be safe, feasible and provide potential therapeutic benefits for locally advanced, resectable esophageal squamous cell carcinoma by the PALACE-1 trial. This subsequent multicenter single-arm PALACE-2 trial will evaluate the efficacy and further confirm the safety of this newly developed neoadjuvant regimen.
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