Actively Recruiting
Brachytherapy With Radiotherapy and Immunotherapy: Guided HDR Trial in Esophageal Squamous Cell Carcinoma
Led by National Taiwan University Hospital · Updated on 2025-09-03
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if adding high-dose-rate (HDR) brachytherapy can improve outcomes in patients with locally advanced esophageal squamous cell carcinoma (ESCC) who have already received external beam radiotherapy (EBRT), chemotherapy, and the immune therapy drug nivolumab. The main questions it aims to answer are: * Does HDR brachytherapy reduce the chance of the cancer coming back in the esophagus or nearby areas within 12 months? * What side effects or safety issues occur when HDR brachytherapy is given after EBRT, chemotherapy, and nivolumab? Participants will: * Receive 1-2 sessions of HDR brachytherapy delivered through a thin tube placed inside the esophagus, within three weeks after starting nivolumab. * Continue nivolumab and be monitored with regular follow-up visits, imaging tests, and blood samples to check treatment response and safety.
CONDITIONS
Official Title
Brachytherapy With Radiotherapy and Immunotherapy: Guided HDR Trial in Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years with ECOG performance status 0-2
- Locally advanced esophageal squamous cell carcinoma, clinical stage III or IVA, biopsy confirmed
- Prior treatment with external beam radiotherapy (40-50.4 Gy in 20-28 fractions) and platinum plus fluoropyrimidine chemotherapy
- Residual or progressive disease and deemed inoperable or unable to have surgery
- No prior immune checkpoint inhibitor exposure and received first cycle of nivolumab after chemoradiotherapy
- Biopsy showing PD-L1 tumor cell expression of 1% or higher
- At least one measurable or non-measurable lesion per RECIST version 1.1
- Patients with limited stage IVB disease with locally dominant primary tumor suitable for brachytherapy as judged by investigator
You will not qualify if you...
- History of severe hypersensitivity to any antibody products
- Symptomatic or treated brain or meningeal metastasis
- Active, known, or suspected autoimmune disease
- Esophageal lumen stenosis preventing brachytherapy
- Involvement of tracheal or bronchial mucosa
- Lesion distribution exceeding 10 cm in range
- Participation in other interventional immunotherapy clinical trials
- Scheduled to undergo esophagostomy
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital Yunlin Branch
Huwei, Yunlin County, Taiwan, 632
Actively Recruiting
Research Team
Y
Yen-Ting Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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