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New combo therapy aims to make inoperable bile duct cancer eligible for transplant

NCT ID NCT07471165

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial tests whether combining an immunotherapy drug (PD-L1 inhibitor) with chemotherapy and radiation can shrink advanced bile duct tumors enough to allow a liver transplant. The study will enroll 25 adults with locally advanced perihilar cholangiocarcinoma that cannot be surgically removed. The main goal is to see how many patients successfully complete the treatment and receive a transplant.

What this could mean

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

Active substance
PD-L1 monoclonal antibody (a type of immunotherapy) combined with chemotherapy (gemcitabine, cisplatin, capecitabine) and radiotherapy
What this could lead to
If successful, this approach could help more patients with advanced bile duct cancer become eligible for a life-saving liver transplant.
What could go wrong
This is a small, early-phase trial with only 25 participants, so results may not apply widely. The combination therapy also carries risks of serious side effects from chemo, radiation, and immunotherapy.

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 25 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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 70 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: The patient voluntarily participates in this study and signs an informed consent form. The patient is aged between 18 and 70 years old. The patient has pathologically confirmed locally advanced perihilar cholangiocarcinoma (pCCA) without concurrent lymph node or distant metastasis, and meets at least one of the following criteria: 1. Bile duct invasion: involvement of bilateral secondary bile ducts. 2. Portal vein invasion: involvement of unilateral or bilateral branches and the main trunk. 3. Hepatic artery invasion: involvement of unilateral or bilateral branches. 4. Liver invasion: involvement of liver parenchyma or insufficient residual liver volume. The patient has at least one measurable lesion (as per RECIST 1.1 criteria). The patient has an ECOG performance status score of 0 to 1. The patient has not received any prior systemic or local therapy. The patient has adequate organ and bone marrow function, and laboratory test results meet the following requirements: 1. Hemoglobin ≥ 90 g/L. 2. Absolute neutrophil count ≥ 1.5 × 10\^9/L. 3. Platelet count ≥ 100 × 10\^9/L. 4. Liver function classified as Child-Pugh A, with total bilirubin ≤ 3 times the upper limit of normal (ULN). 5. ALT and AST ≤ 3 times ULN; for patients with obstructive jaundice, if liver function indicators meet the inclusion criteria after treatment with PTCD or ERCP, they may be considered for inclusion. 6. Serum creatinine ≤ 1.5 times ULN; endogenous creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula). 7. Urine protein \< (++), or 24-hour urine protein \< 1.0 g. The patient has normal coagulation function and no active bleeding: 1. International normalized ratio (INR) ≤ 1.5. 2. Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. If the subject has HBV or HCV infection, the following conditions must be met: 1. For inactive/asymptomatic HBV carriers or chronic/active HBV carriers: HBV deoxyribonucleic acid (DNA) \< 2000 copies/mL during screening. (Note: Patients with HBV DNA \> 2000 copies/mL should be treated according to treatment guidelines. Patients receiving antiviral therapy at the time of screening should have HBV-DNA \< 2000 copies/mL and continue treatment during the study.) 2. For subjects infected with HCV: if infection is confirmed by detectable HCV ribonucleic acid (RNA), such subjects cannot be included in the group. No pregnancy or plans for pregnancy: If you are a woman of childbearing potential (i.e., physically capable of becoming pregnant), you must agree to use effective contraception during the study and for 120 days after the last dose, and have a negative urine or serum pregnancy test within 7 days before the first dose. If you are a non-sterilized male, you need to agree to use effective contraception during the study and for 120 days after the last dose. \- Exclusion Criteria: Diagnosed with intrahepatic cholangiocarcinoma, distal cholangiocarcinoma, or gallbladder cancer. Concurrent lymph node or distant metastasis. Previous systemic treatment for biliary tract tumors. History of severe hypersensitivity reactions to other monoclonal antibodies. Allergy to durvalumab, adebrelimab, or any of their excipients; allergy to gemcitabine or any of its excipients; allergy to cisplatin or any of its excipients. Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites within 7 days before treatment, defined as meeting the following criteria: (a) ascites detectable by physical examination during screening, or (b) ascites requiring paracentesis during screening. Any bleeding or thrombotic disorder or any need for anticoagulants requiring monitoring of the international normalized ratio (e.g., warfarin or similar drugs) within 6 months before treatment initiation. Presence of any malignancy other than the cholangiocarcinoma under study in this clinical trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ, occult thyroid cancer). Presence of any known central nervous system metastases and/or leptomeningeal disease before treatment. Any active immunodeficiency or autoimmune disease likely to recur at screening and/or any history of immunodeficiency or autoimmune antibody disease. Patients with immune system diseases requiring daily administration of more than 10 mg of dexamethasone. History of interstitial lung disease or non-infectious pneumonitis. Any severe chronic or active infection (excluding viral hepatitis) requiring systemic antibacterial, antifungal, or antiviral treatment (e.g., tuberculosis) before treatment initiation. Electrocardiogram (ECG) during screening shows a heart rate-corrected QT interval (QTc) (corrected using the Fridericia method) exceeding 450 milliseconds; Note: If any patient has a QTc interval exceeding 450 milliseconds on the first ECG, the ECG will be repeated to confirm the result. Any of the following cardiovascular risk factors: cardiogenic chest pain within 28 days before treatment, defined as moderate pain limiting daily activities (ADLs). Symptomatic pulmonary embolism within 28 days before treatment. History of acute myocardial infarction within 6 months before treatment. Any history of heart failure reaching New York Heart Association Class III or IV within 6 months after treatment, ventricular arrhythmia of Grade 2 or higher within 6 months before treatment, cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months before treatment. Organ transplantation or hematopoietic stem cell transplantation (HSCT) or any major surgery within 28 days before treatment. Known psychiatric or substance abuse disorders that may interfere with test compliance. Vaccination with a live vaccine within 28 days before treatment. Note: Seasonal influenza vaccines are generally inactivated and are permitted. Known history of human immunodeficiency virus (HIV) infection or syphilis infection. Any history or evidence of disease, treatment, or laboratory abnormalities that may confound test results, interfere with the subject's participation throughout the trial, or be deemed by the principal investigator as not in the subject's best interest. Pregnancy or lactation, or anticipated pregnancy or childbirth during the planned duration of the trial, from the screening visit to 120 days after the last dose. Poor compliance as judged by the investigator, or other conditions that make the patient unsuitable for participation in this trial. Various medical contraindications preventing the use of enhanced imaging (CT or MRI). The investigator deems the patient unsuitable for inclusion. \-

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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

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

  1. The places running it

    2 sites. 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

  • Jinling Hospital of Nanjing University

    Nanjing, Jiangsu, 210000, China

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210002, China