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Resectable Biliary Tract CancerPhase 2NCT05640791

Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

A Phase 2 study testing Cisplatin, Gemcitabine and Nab-paclitaxel in people with Resectable Biliary Tract Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Resectable Biliary Tract Cancer
What is being tested?
Cisplatin, Gemcitabine and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
12 Jan 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The pathological diagnosis has confirmed biliary tract malignancy;pathological evidence may be obtained from biopsy/puncture, surgical resection specimens, or a formal pathology report.
  • 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
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  • Suspicious or involved regional lymph nodes (N1)
  • No distant extrahepatic disease (M0)
  • The patient's gender is not limited, and the age is 18-75 years old; Life expectancy>3 months;
  • Within one week of enrollment, the ECOG PS score was 0 or 1;
  • No serious complications, such as hypertension, coronary heart disease and psychiatric history, and no serious allergic history; Non pregnancy and non lactation period;
  • 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
  • The patient can understand and sign the informed consent form to participate in the trial study; can follow up with good compliance.

Who cannot join

  • 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);
  • Used any other research drugs within 4 weeks before enrollment;
  • 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;
  • 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;
  • 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;
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
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  • Test drug allergy;
  • Suffering from uncontrollable mental illness;
  • 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)";
  • 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;
  • Pregnancy (positive pregnancy test) or lactation;
  • 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;
  • Other cancers in the past (within the past 5 years) or at the same time, excluding non melanoma skin cancer and carcinoma in situ;
  • History of allergy or hypersensitivity to any study drug;
  • Current abuse of alcohol or illicit drugs;
  • Unable or unwilling to sign the informed consent form.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huikai Li, M.D. contact

+8618622228639

tjchlhk@126.com

China1 site, 1 recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300308

    Huikai Li, MD, 18622228639, tjchlhk@126.com

    Yayue Liu, Doctor, 18822002320

    Recruiting

Other trials in China

About this study

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

This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Cisplatinum

    25mg/m2；d1, 8, 21 d cycle

  • GemcitabineDrug

    Also called Difluorodeoxycytidine hydrochloride

    1000mg/m2；d1, 8, 21 d cycle

  • Nab-paclitaxelDrug

    Also called ABI-007

    100mg/m2；d1, 8, 21 d cycle

  • DurvalumabDrug

    Also called MEDI4736

    1000mg；d1, 21 d cycle

Study groups in NCT05640791
Study groupRoleWhat they receive
Gemcitabine, cisplatin, nab-paclitaxel, durvalumabExperimentalParticipants receive nab-paclitaxel over 30 minutes, cisplatin over 60 minutes, and gemcitabine over 30 minutes on days 1 and 8; durvalumab over 60 minutes on days 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of completion of all preoperative and operative therapy

    Completion of all therapy rate will be recorded

    Measured: Up to 9 weeks after study start

  2. Incidence of adverse events

    Will be monitored using method of Thall, Simon and Estey, and will be tabulated by the maximum reported Common Terminology Criteria for Adverse Events (CTCAE) grade.

    Measured: Up to 1 years after study start

Secondary outcomes (4)

  1. Response rate defined as the percentage of patients who will have complete response (CR), partial response (PR) or stable disease (SD) after the neoadjuvant therapy

    Will be evaluated according to Response Evaluation Criteria in Solid Tumor (RECIST).

    Measured: Up to 9 weeks after study start

  2. Rate of R0 resection

    R0 resection is defined as no tumor remains at the cutting edge and no tumor cells remain at the cutting edge under the microscope

    Measured: Up to 9 weeks after study start

  3. Recurrence-free survival (RFS)

    RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. If a patient did not have an event (i.e. disease recurrence or death) by the time of final analysis, patient will be censored at the last disease evaluation time.

    Measured: Up to 1 years after study start

  4. Overall survival (OS)

    OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.

    Measured: Up to 1 years after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start12 Jan 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05640791
Sponsor's protocol ID
D20220930
Status last verified
Jul 2026
First submitted
30 Nov 2022
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Gemcitabine and Nab-paclitaxel in people with Resectable Biliary Tract Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huikai Li, M.D. (+8618622228639, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of completion of all preoperative and operative therapy (time frame: Up to 9 weeks after study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05640791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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