NCT07164690

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

Low-Dose Radiotherapy in Patients With Advanced Esophageal Squamous Cell Carcinoma Resistant to First-Line Chemotherapy Combined With Immunotherapy: a Phase II, Single-arm Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Esophageal Adenocarcinoma
• Radiotherapy

Interventions

Type	Name	Description
RADIATION	Low Dose Radiation Therapy	A dose of 2 Gy/1Fx will be delivered to all currently visible lesions. Lesions in different anatomic sites may be irradiated separately, but the entire course must be completed within one week. * Esophageal primary tumor management: If the investigator judges there is a risk of fistula or bleeding from the esophageal lesion, palliative radiotherapy at 40-50 Gy may be added. * Immunotherapy: The original PD-1/PD-L1 inhibitor regimen will be resumed immediately after LDRT is completed and continued as maintenance therapy. * Chemotherapy: At the investigator's discretion, standard second-line chemotherapy per the current CSCO guidelines for esophageal cancer may be administered.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-09-10
• Last updated: 2025-09-10