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New trial burns tumors from inside to fight bile duct cancer

NCT ID NCT07235007

Disease control Sponsor: Aichi Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a procedure called endobiliary radiofrequency ablation (EB-RFA) can help people with advanced bile duct cancer live longer. EB-RFA uses a catheter to deliver heat directly to the tumor inside the bile duct. Half of the 120 participants will receive EB-RFA plus a plastic stent, while the other half get only the stent. Everyone also receives standard chemotherapy and immunotherapy. The main goal is to see if the added ablation improves overall survival.

What this could mean

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

Active substance
Endobiliary radiofrequency ablation (EB-RFA) using a catheter device, plus a plastic biliary stent
What this could lead to
If successful, this could extend survival for people with advanced bile duct cancer by combining a local tumor-burning procedure with standard chemotherapy and immunotherapy.
What could go wrong
This is an early-phase trial with only 120 participants, so results may not apply to everyone. The procedure carries risks like bile duct injury or infection, and the added benefit over standard care is uncertain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Started

Nov 2025

Expected to finish

Dec 2030

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 years and older

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: Histologically or cytologically confirmed extrahepatic cholangiocarcinoma (eCCA). Unresectable disease (unresectable due to tumor/patient factors, or patient refusal of surgery). Biliary obstruction requiring drainage, demonstrated by abnormal cholestatic liver tests, elevated bilirubin, radiologic evidence, or existing biliary drainage. Planned initiation of first-line systemic therapy with durvalumab + gemcitabine + cisplatin (GCD). Age ≥18 years. Able to provide written informed consent. Exclusion Criteria: Prior radiotherapy or systemic therapy for the current eCCA. Presence of a self-expanding metal stent that cannot be endoscopically removed. Surgically altered anatomy except for Billroth-I; prior biliary reconstruction. History of chronic cholangitis (e.g., primary sclerosing cholangitis, IgG4-related cholangitis). Expected survival \<3 months. Inability to insert an oral endoscope or reach the papilla. Contraindication to endobiliary RFA. Pregnancy or possible pregnancy. Any condition judged unsuitable by the investigator.

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Conditions

The condition(s) this trial relates to.

Biliary Tract Neoplasms cholangiocarcinoma extrahepatic bile duct carcinoma

As listed by the trial registrant

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

Extrahepatic cholangiocarcinoma

How to take part

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

  1. The places running it

    8 sites in 2 countries. 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

  • Aichi Medical University

    RECRUITING

    Aichi, Japan

  • Gangnam Severance Hospital, Yonsei University College of Medicine

    RECRUITING

    Seoul, South Korea

  • Gifu University Hospital

    RECRUITING

    Gifu, Japan

  • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

    RECRUITING

    Seoul, South Korea

  • Nagoya City University Hospital

    RECRUITING

    Aichi, Japan

  • Nagoya City University Midori Municipal Hospital

    RECRUITING

    Aichi, Japan

  • Pusan National University Hospital

    RECRUITING

    Busan, South Korea

  • Severance Hospital, Yonsei University College of Medicine

    RECRUITING

    Seoul, South Korea

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