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Triple therapy shrinks bile duct tumors, may enable surgery

NCT ID NCT07030140

Disease control Sponsor: Jinbo Yue 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests a combination of immunotherapy (tislelizumab), chemotherapy (gemcitabine plus cisplatin or oxaliplatin), and targeted radiation before possible surgery in 38 people with hilar cholangiocarcinoma that is borderline or not removable. The goal is to see if this approach can shrink tumors enough to allow complete surgical removal and improve overall survival. Participants who become eligible for surgery will have it; others will continue with more cycles of the drug combination.

What this could mean

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

Active substance
tislelizumab (an immunotherapy drug), gemcitabine, cisplatin or oxaliplatin, and stereotactic body radiotherapy
What this could lead to
If successful, this combination could shrink tumors enough to allow surgery in patients who otherwise cannot have it, potentially improving survival for this rare bile duct cancer.
What could go wrong
This is a small, early-phase trial with only 38 participants and no comparison group. The combination of immunotherapy, chemo, and radiation may cause significant side effects, and it is not yet known if it will improve long-term outcomes.

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 38 people

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

Started

Jul 2025

Expected to finish

Jan 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 75 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 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma * Borderline resectable or unresectable disease based on imaging and MDT evaluation * ECOG performance status 0-1 * Adequate hematologic, hepatic, and renal function * No prior anti-tumor therapy for current diagnosis * Expected survival ≥ 3 months * Signed informed consent Exclusion Criteria: * Evidence of distant metastasis * Prior treatment with immune checkpoint inhibitors * Uncontrolled infection or serious medical comorbidities * Active autoimmune disease requiring systemic therapy * History of organ transplantation or immunodeficiency * Pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

bile duct cancer bile duct neoplasm Biliary Tract Neoplasms cholangiocarcinoma hilar cholangiocarcinoma

As listed by the trial registrant

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

Bile duct cancer Cholangiocarcinoma Hilar cholangiocarcinoma

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

  • Shandong Cancer Hospital and Institute

    RECRUITING

    Jinan, Shandong, 250117, China

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