Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients

Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.

Inclusion Criteria:Pathologically confirmed esophageal squamous cell carcinomaPotentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0)Treatment-naiveExpected life span > 6 monthsAged 18 - 75 years oldAdequate organ functionsPS 0-2Participants are fully informed about the whole study and are willing to sign the informed consentExclusion Criteria:Previous history of thoracic surgery or radiationCervical or multi-origin esophageal cancerKnown or suspected experimental drug allergyPregnant or lactating womenEsophagomediastianl fistulaPeripheral neuropathyPrevious cancer history other than esophageal cancerSevere organ function deterioration that can not tolerate neoadjuvant therapyPrevious autoimmune diseasesdiabetic history > 10 yearsinterstitial pulmonary disease, non-infectious pulmonitisActive type B hepatitisAny other conditions that may affect patients' safety and compliance