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New drug cocktail aims to stop bile duct cancer from coming back

NCT ID NCT07561775

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a combination of two drugs—adebrelimab (given by IV) and S-1 (taken as pills)—can help prevent bile duct cancer from returning after surgery. About 40 adults who had their cancer fully removed will receive the treatment for about 4 months and be monitored for side effects and cancer recurrence. The goal is to see if this approach improves the chance of staying cancer-free one year after surgery.

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 40 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jan 2032

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: * Histologically or pathologically confirmed malignant cholangiocarcinoma. * Patients who have undergone curative surgical resection. * Age between 18 and 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected survival time \>3 months. * Adequate organ and bone marrow function, including:Absolute neutrophil count ≥1.5 × 10\^9/L,Platelet count ≥75 × 10\^9/L,Hemoglobin ≥90 g/L,Total bilirubin ≤1.5 × upper limit of normal (ULN),AST and ALT ≤2.5 × ULN,Albumin ≥3 g/dL,Serum creatinine ≤1.5 × ULN. * Ability to understand and willingness to sign written informed consent. * For patients of childbearing potential, willingness to use effective contraception during the study and for at least 1 month after the last dose; negative pregnancy test within 72 hours prior to enrollment. Exclusion Criteria: * Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory or co-inhibitory pathways (e.g., CTLA-4, CD137). * Use of any investigational drug within 4 weeks prior to enrollment. * Active autoimmune disease or history of autoimmune disease (e.g., interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism requiring hormone replacement). * Known immunodeficiency, including HIV infection, active hepatitis B (HBV DNA \>500 IU/mL), active hepatitis C (HCV RNA above detection limit), or co-infection of HBV and HCV. * Severe infection within 4 weeks prior to first dose or unexplained fever \>38.5°C during screening. * History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Uncontrolled psychiatric disorders. * Severe or uncontrolled comorbidities that may interfere with study participation (e.g., unstable angina, myocardial infarction within 6 months, symptomatic arrhythmia, congestive heart failure, uncontrolled diabetes, or uncontrolled infection). * History of other malignancies within the past 5 years, except for non-melanoma skin cancer or carcinoma in situ. * Known hypersensitivity to study drugs or monoclonal antibodies. * Inability or unwillingness to provide informed consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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