Electronic patient-reported outcome-based surveillance system to evaluate safety and efficacy of preoperative immunochemotherapy with or without short-term chemoradiation in patients with esophageal squamous cell carcinoma (ePRO-PICCRT): protocol for a prospective, single-arm, phase II study.

Background: Radiation-associated adverse events (ADEs) in patients with esophageal squamous cell carcinoma (ESCC) remain a problem. Recent research has focused on reducing radiation-associated ADEs while maintaining efficacy, particularly through the combination of immune checkpoint inhibitors (ICIs) with chemotherapy. Patient-reported outcomes (PROs) have also emerged as reliable measures for monitoring treatment effectiveness and quality of life (QoL). This trial aims to investigate the feasibility of using patient-reported dysphagia relief to assess pathological response following neoadjuvant immunochemotherapy, as well as the safety and efficacy of neoadjuvant immunochemotherapy combined with short-course radiotherapy for patients with locally advanced ESCC. Methods: This study is designed as a prospective, single-arm, phase II study. Eligible ESCC patients will be invited to participate in this study. All participants will receive paclitaxel (albumin-bound) (260 mg/m Discussion: This study will provide evidence for using patient-reported dysphagia relief to evaluate pathological response after neoadjuvant immunochemotherapy in early remission (Group A) and to evaluate the safety and efficacy of combining immunochemotherapy with short-course radiotherapy in latent remission (Group B) among patients with ESCC. Limitations include the single-arm study design, small sample size, and the need for further exploration of the specific mechanism and mediator of early dysphagia remission's effect on immunochemotherapy effectiveness. Trial Registration: This study is registered at Clinicaltrials.gov (NCT05596890).