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Internal radiation boost may help fight esophageal cancer when standard treatment fails

NCT ID NCT07152678

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding high-dose-rate brachytherapy (internal radiation) to the immune therapy drug nivolumab can improve outcomes for people with advanced esophageal cancer that has not been fully controlled by standard chemoradiation. About 60 participants will receive 1-2 sessions of brachytherapy along with continued nivolumab. The study will track how many patients remain cancer-free in the chest area after 12 months and monitor for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab (immune therapy drug) and high-dose-rate brachytherapy (internal radiation)
What this could lead to
If successful, this combination could reduce the chance of esophageal cancer returning in the chest area after standard treatment.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. Adding brachytherapy to immune therapy could increase side effects like inflammation or damage to the esophagus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms esophageal squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal cancer Esophageal squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Taiwan University Hospital Yunlin Branch

    RECRUITING

    Huwei, Yunlin County, 632, Taiwan

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