Overview
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.
Eligibility
Inclusion Criteria:
- Pathologically confirmed esophageal squamous cell carcinoma
- Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0)
- Treatment-naive
- Expected life span > 6 months
- Aged 18 - 75 years old
- Adequate organ functions
- PS 0-2
- Participants are fully informed about the whole study and are willing to sign the informed consent
Exclusion Criteria:
- Previous history of thoracic surgery or radiation
- Cervical or multi-origin esophageal cancer
- Known or suspected experimental drug allergy
- Pregnant or lactating women
- Esophagomediastianl fistula
- Peripheral neuropathy
- Previous cancer history other than esophageal cancer
- Severe organ function deterioration that can not tolerate neoadjuvant therapy
- Previous autoimmune diseases
- diabetic history > 10 years
- interstitial pulmonary disease, non-infectious pulmonitis
- Active type B hepatitis
- Any other conditions that may affect patients' safety and compliance
