drugset / Trial / NCT05596890

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

NCT05596890 ↗

Phase 2 Unknown 50 enrolled Guangdong Provincial People's Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-11-30
Primary completion
2025-09-30
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Cisplatin Other / unclassified 60 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous