Clinical Trial

PD-1 Inhibitors Combined With Local Therapy at Different Timings in Oligometastatic ESCC

Study acronym: ESO-shanghai31
Recruiting
View on ClinicalTrials.gov →
Summary
Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients. Several studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus. To clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.
Trial Details
NCT Number NCT07697859
Lead Sponsor Fudan University
Conditions Esophageal Squamous Cell Carcinoma (ESCC)
Enrollment 354 participants
Start Date 2026-07-15
Primary Completion 2029-07-15 (estimated)
Study Completion 2031-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-13