New drug cocktail aims to stop bile duct cancer from coming back
NCT ID NCT07561775
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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