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

Sponsor
Fudan University
Study ID
NCT07164690
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Esophageal Adenocarcinoma
  • Radiotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low Dose Radiation Therapy — RADIATION
    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.

Study Details

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

Key Dates

First listed
Sep 10, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LDRT

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 1 year ]

Central Contacts

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