Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Durvalumab with chemotherapy before surgery for biliary tract cancer

Official title: Phase II, Single-arm, Exploratory Study to Evaluate the Safety and Effectiveness of Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Run by Tianjin Medical University Cancer Institute and Hospital · NCT05640791 · Data updated 2026-11-12

This phase II trial tests a combination of durvalumab with gemcitabine, cisplatin, and nab-paclitaxel before surgery in people with resectable biliary tract cancer to see if it helps shrink tumors and improve outcomes.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment40 (estimated)
SponsorTianjin Medical University Cancer Institute and Hospital
Academic / other
Drugs / interventionsdurvalumab, chemotherapy
Locations1 site (Tianjin, Tianjin Municipality)
StatusRecruiting
StartedJanuary 12, 2023
Main results expectedDecember 31, 2023
Study endsDecember 31, 2026
Registry record updatedJuly 16, 2026
Trial IDNCT05640791 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18-75 with resectable biliary tract cancer, meeting specific imaging and tumor criteria, and adequate organ function.

Probably not a fit

Patients with distant metastasis, non-resectable disease, or insufficient organ function may not benefit from this neoadjuvant therapy.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter phase II study, participants with resectable biliary tract cancer receive a preoperative regimen of gemcitabine, cisplatin, nab-paclitaxel, and durvalumab to see if the tumor can be reduced prior to surgical removal. The approach builds on prior evidence that adding durvalumab to gemcitabine and cisplatin may improve survival in advanced biliary tract cancer. Drugs are given in combination to target tumor cells through different mechanisms, potentially facilitating complete resection and sparing normal tissue. The trial focuses on safety, feasibility, and preliminary signals of efficacy in the neoadjuvant setting.

Why it matters

Potential benefit: If successful, the treatment could shrink tumors before surgery and improve the chances of a complete and successful operation.

How similar studies have gone: Prior evidence in biliary tract cancer suggests benefit from durvalumab with gemcitabine and cisplatin in advanced disease, but neoadjuvant data are still evolving.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Tianjin Cancer Hospital Airport Hospital
    Tianjin, Tianjin Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.