Brachytherapy With Radiotherapy and Immunotherapy: Guided HDR Trial in Esophageal Squamous Cell C… (NCT07152678) | Clinical Trial Compass
RecruitingPhase 2
Brachytherapy With Radiotherapy and Immunotherapy: Guided HDR Trial in Esophageal Squamous Cell Carcinoma
Taiwan60 participantsStarted 2025-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age of 18-85 years, with ECOG performance 0-2.
* Locally-advanced esophageal squamous cell carcinoma with clinical stage III, IVA with biopsy proven.
* Prior treatment with EBRT (40-50.4 Gy in 20-28 fractions) and platinum + fluoropyrimidine chemotherapy, with residual or progressive disease, and deemed inoperable or unable to undergo surgery.
* No prior exposure to ICIs and had received first cycle of nivolumab after CCRT.
* Biopsy proven with PD-L1 \[tumor cell (TC) ≥ 1%\]
* Required at least one measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
* Patients with limited stage IVB disease (e.g., non-visceral lymph node metastasis) may be enrolled if the primary tumor is locally dominant and suitable for brachytherapy, based on investigator's discretion.
Exclusion Criteria:
* Current or past history of severe hypersensitivity to any other antibody products.
* Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment.
* Patients with active, known or suspected autoimmune disease
* Stenosis of esophageal lumen that cannot performed brachytherapy
* Involvement of tracheal mucosa or bronchial mucosa.
* The distribution of the lesions of interest exceeds 10 cm range.
* The patient is participating in other interventional clinical trials associated with immunotherapy.
* The patient is scheduled to undergo esophagostomy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence of locoregional failure at 12 months
Timeframe: 12 months from initiation of HDR brachytherapy