Could a drug combo shrink bile duct tumors before surgery?

NCT ID NCT05640791

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial tests whether giving the immunotherapy drug durvalumab along with chemotherapy before surgery can shrink biliary tract cancers and improve outcomes. About 40 people with resectable tumors will receive the combination, then undergo surgery. The goal is to see if this approach is safe and helps remove the cancer more completely.

What this could mean

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

Active substance
a combination of durvalumab, gemcitabine, cisplatin, and nab-paclitaxel
What this could lead to
If successful, this approach could make surgery more effective for biliary tract cancer by shrinking tumors beforehand, potentially improving survival.
What could go wrong
This is a small, early-phase trial with no control group, so results may not confirm benefit. Side effects from the drug combination could be significant.

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.

Started

Jan 2023

Expected to finish

Dec 2026

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: 1. The pathological diagnosis has confirmed biliary tract malignancy;pathological evidence may be obtained from biopsy/puncture, surgical resection specimens, or a formal pathology report. 2. Computed tomography (CT) or magnetic resonance imaging (MRI) shall be performed with high-quality cross-sectional imaging, and diagnosed as resectable high-risk biliary malignant tumors, limited to the liver, bile duct and/or regional lymph nodes (at least one of the following criteria must be met) : * T-stage ≥ Ib (Ib-IV) * Solitary lesion \> 5 cm * Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable * Presence of major vascular invasion but still technically resectable * Suspicious or involved regional lymph nodes (N1) * No distant extrahepatic disease (M0) 3. The patient's gender is not limited, and the age is 18-75 years old; Life expectancy\>3 months; 4. Within one week of enrollment, the ECOG PS score was 0 or 1; 5. No serious complications, such as hypertension, coronary heart disease and psychiatric history, and no serious allergic history; Non pregnancy and non lactation period; 6. The patient's organ and blood system functions meet the requirements: * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L * Platelet count ≥ 100 × 10\^9/L * Hemoglobin ≥ 90 g/L * Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN * Albumin ≥ 3g/dL * Creatinine ≤ 1.5 x ULN 7. The patient can understand and sign the informed consent form to participate in the trial study; can follow up with good compliance. Exclusion Criteria: 1. Patients who received PD-1, PD-L1, PD-L2, CTLA-4 inhibitors before enrollment, or patients who directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, CD137); 2. Used any other research drugs within 4 weeks before enrollment; 3. Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); Patients with childhood asthma who have completely alleviated and do not need any intervention or leukorrhea after adulthood can be included, but patients who need medical intervention with bronchodilators cannot be included; 4. With congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method) or people with hepatitis B and hepatitis C co infection; 5. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\>38.5 ° C occurred during screening/before the first drug administration; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Test drug allergy; 8. Suffering from uncontrollable mental illness; 9. Peripheral neuropathy of grade 2 or above according to CTCAE 4.0. In CTCAE 4.0, grade 2 sensory neuropathy is defined as "moderate symptoms; restriction of activities of daily living (ADL)"; 10. Occurrence of serious and/or uncontrollable diseases at the same time may affect participation in the study, such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, diabetes out of control, severe activity, uncontrollable infection after inadequate biliary drainage (such as tumor blocking the bile duct), or mental disease/social condition; 11. Pregnancy (positive pregnancy test) or lactation; 12. Diseases of central nervous system (CNS), except for brain metastasis treated. The treated brain metastatic tumor is defined as confirmed by clinical examination and brain imaging (MRI or CT) during the screening period, and there is no sign of progress or bleeding after treatment, and there is no need for continuous application of dexamethasone. Anticonvulsant drugs (stable dosage) are allowed. The treatment of brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, linear accelerator \[LINAC\] or equivalent) or a combination deemed appropriate by the treating doctor. Patients with central nervous system metastasis who underwent neurosurgical resection or brain biopsy within 3 months before the first day were excluded; 13. Other cancers in the past (within the past 5 years) or at the same time, excluding non melanoma skin cancer and carcinoma in situ; 14. History of allergy or hypersensitivity to any study drug; 15. Current abuse of alcohol or illicit drugs; 16. Unable or unwilling to sign the informed consent form.

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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

    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

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Contacts and locations

Locations

  • Tianjin Cancer Hospital Airport Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300308, China