Clinical Trial

Low-Dose Radiotherapy in Patients With Advanced Esophageal Squamous Cell Carcinoma Resistant to First-Line Chemotherapy Combined With Immunotherapy

Not Yet Recruiting Phase 2
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Record status
This record was last updated September 10, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
Brief Summary The goal of this single-arm Phase II clinical trial is to learn whether low-dose radiotherapy (LDRT) can restore sensitivity to immunotherapy and prolong disease control in adults with advanced esophageal squamous cell carcinoma who have progressed after first-line chemotherapy combined with PD-1/PD-L1 inhibitors. The main questions it aims to answer are: * Can LDRT followed by continued immunotherapy increase progression-free survival compared with historical data? * What is the objective response rate after adding LDRT to ongoing immunotherapy? * Is LDRT combined with immunotherapy safe in this heavily pre-treated population? Participants will: * Receive a single fraction of 2 Gy to every visible metastatic lesion within one week * Continue their prior PD-1/PD-L1 inhibitor (e.g., camrelizumab, pembrolizumab) after LDRT is completed * Undergo tumor imaging every 6 weeks for up to one year to monitor response * Provide optional blood and tissue samples for exploratory biomarker studies
Trial Details
NCT Number NCT07164690
Lead Sponsor Fudan University
Conditions Esophageal Adenocarcinoma, Radiotherapy
Enrollment 32 participants
Start Date 2025-09
Primary Completion 2026-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-09-10