Could a drug combo shrink bile duct tumors before surgery?
NCT ID NCT05640791
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
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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.
- Started
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Jan 2023
- Expected to finish
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Dec 2026
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: 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.
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The places running it
1 site. The list below names each one and where it is.
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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
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
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Tianjin Cancer Hospital Airport Hospital
RECRUITINGTianjin, Tianjin Municipality, 300308, China