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Distal Bile Duct AdenocarcinomaPhase 1NCT05285358

Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases

A Phase 1 study testing Cisplatin, Gemcitabine and Nab-paclitaxel in people with Distal Bile Duct Adenocarcinoma and Gallbladder Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This phase I trial studies the side effects of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, Gemcitabine and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
19 Sep 2022to 11 Oct 2028
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Age: >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Histologically or cytologically confirmed intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer
  • Documented metastatic disease on computed tomography (CT) imaging or magnetic resonance imaging (MRI). CT scan or MRI to assess measurable disease must have been completed within 28 days prior to registration
  • Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Fully recovered from acute toxic effects (except alopecia, hearing loss, or non-clinically significant laboratory abnormalities) =< grade 1 of prior anti-cancer therapy
  • Complete medical history and physical exam (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Absolute neutrophil count (ANC) >= 1,500/mcL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Platelets >= 100,000/mcL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Hemoglobin >= 8 g/dL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Serum albumin >= 2.8 g/dL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin < 1.5 mg/dL) (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Aspartate aminotransferase (AST) =< 5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Alanine aminotransferase (ALT) =< 5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Calculated creatinine clearance of >= 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • If seropositive, patient may be eligible if they are stable on antiretroviral therapy, have a CD4 T cell count >= 200/µL, and have an undetectable viral load
  • Documented virology status of hepatitis, confirmed by hepatitis B virus (HBV) and hepatitis C virus (HCV) tests (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • For patients with active HBV, HBV deoxyribonucleic acid (DNA) < 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to day 1 of cycle 1, and willingness to continue anti-HBV treatment during the study (per standard of care)
  • If seropositive for HCV, nucleic acid quantification must be performed. Viral load must be undetectable
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential* to use an effective method of birth control (e.g. licensed hormonal/barrier methods or surgery intended to prevent pregnancy [or with a side effect of pregnancy prevention]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • Any prior systemic therapy treatment for advanced cholangiocarcinoma or gallbladder cancer
  • Any prior adjuvant therapy (chemotherapy, radiation therapy, biological therapy, immunotherapy) completed < 6 months prior to registration
  • Strong CYP3A4 inducers/inhibitors within 14 days prior to day 1 of protocol therapy
  • Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or exclusive total parenteral nutrition
  • Evidence of liver metastases with >= 50% liver occupation
  • Any history of, or current, brain or subdural metastases
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  • Life expectancy < 3 months
  • History of peripheral neuropathy >= grade 2 measured by NCI CTCAE version 5.0 ("moderate symptoms, limiting instrumental activities of daily living")
  • Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment
  • Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved
  • Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (platinum-based compounds, etc.)
  • Clinically significant uncontrolled illness
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

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

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Daneng Li, MD, 626-471-9200, danli@coh.org

    Daneng Li, MD

    Recruiting

Other trials in United States

About this study

Official title: Safety of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Biliary Tract Cancer Patients With Peritoneal Metastases

This phase I trial studies the side effects of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases). PIPAC involves the administration of intraperitoneal chemotherapy (anticancer drugs given directly to the lining of the abdomen). PIPAC uses a nebulizer (a device that turns liquids into a fine mist) which is connected to a high-pressure injector and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and insert a camera and other instruments into the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen), which results in the drug reaching more of the tissue as well as reaching deeper into the tissue, which reduces the amount of chemotherapy that needs to be used and potentially reduces side effect. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and cisplatin, 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 nab-paclitaxel via PIPAC in combination with standard of care gemcitabine and cisplatin may reduce side effects and make this chemotherapy regimen more tolerable in patients with biliary tract cancer that has spread to the spread to the peritoneum.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Evaluate the safety of PIPAC nab-paclitaxel in combination with systemic chemotherapy in patients with biliary tract cancer with peritoneal metastases, based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

SECONDARY OBJECTIVES:

  1. Efficacy. II. Post-operative surgical complications by Clavien-Dindo classification evaluated at 4 weeks after each PIPAC.

III. Median overall survival and median progression-free survival. IV. PIPAC technical failure rate. V. Patient-reported health state/quality of life and symptoms before treatment (week 1) and at weeks 7, 13, 19, and 25/off study, as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) and MD Anderson Symptom Inventory (MDASI).

VI. Functional status, as measured by the number of daily steps before and after treatments (Vivofit 4 wristband pedometer - Garmin Company).

EXPLORATORY OBJECTIVES:

  1. Characterization of sub-clonal evolution and tumor microenvironment in response to therapy with a particular focus on immune subsets.

II. Pharmacokinetic and pharmacodynamic evaluations to evaluate the therapeutic advantage of PIPAC nab-paclitaxel delivery.

OUTLINE:

Patients receive gemcitabine intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8. Patients also receive nab-paclitaxel via PIPAC over 5-10 minutes on day 3 of cycles 1, 3, and 5. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

Being tested
Cisplatin, Gemcitabine, Nab-paclitaxel, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Gallbladder Neoplasms, Cholangiocarcinoma

What participants receive

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

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given IV

  • Nab-paclitaxelDrug

    Also called ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel

    Given via PIPAC

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05285358
Study groupRoleWhat they receive
Treatment (gemcitabine, cisplatin, nab-paclitaxel PIPAC)ExperimentalPatients receive gemcitabine IV over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8. Patients also receive nab-paclitaxel via PIPAC over 5-10 minutes on day 3 of cycles 1, 3, and 5. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Nab-paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

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

  1. Incidence of adverse events

    Measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities observed during the first 6 weeks after the first cycle will be summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome.

    Measured: Up to 6 weeks after cycle 1 (1 cycle = 21 days)

Secondary outcomes (8)

  1. Efficacy - RECIST

    Measured by Response Evaluation Criteria in Solid Tumors (RECIST) via computerized tomography (CT) scan.

    Measured: Up to 1 year after completion of chemotherapy

  2. Efficacy - PGRS

    Measured by Peritoneal Regression Grading Score (PGRS) via biopsy at each Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) cycle.

    Measured: Up to 1 year after completion of chemotherapy

  3. Efficacy - PCI

    Measured by Peritoneal Carcinomatosis Index (PCI) at the time of laproscopy.

    Measured: Up to 1 year after completion of chemotherapy

  4. Post-operative surgical complications

    Measured by Clavien-Dindo classification. Results will be strictly descriptive in nature.

    Measured: Up to 4 weeks after each pressurized intraperitoneal aerosolized chemotherapy treatment

  5. Overall survival

    The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

    Measured: From initiation of treatment to death, assessed up to 1 year

  6. Progression-free survival

    Will be described using the Kaplan-Meier method.

    Measured: From initiation of treatment to progression, assessed up to 1 year

  7. Change in patient-reported health state/quality of life and symptoms

    Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire and MD Anderson Symptom Inventory.

    Measured: Before treatment (week 1) up to 1 year

  8. Functional status

    Measured by the number of daily steps before and after treatments (Vivofit 4 wristband pedometer - Garmin Company).

    Measured: Up to 1 year

Timeline

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

  1. First posted17 Mar 2022
  2. Study start19 Sep 2022
  3. Primary completion11 Oct 2028 (estimated)
  4. Study completion11 Oct 2028 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285358
Sponsor's protocol ID
21679
Other IDs
NCI-2022-01766, 21679, P30CA033572
Status last verified
Jul 2026
First submitted
9 Mar 2022
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Li D, Crook C, Chung V, Brar G, Fakih M, Barzi A, Melstrom L, Singh G, Fong Y, Frankel P, Raoof M. Safety of pressurized intraperitoneal aerosolized chemotherapy in biliary cancer patients with peritoneal metastases. Future Oncol. 2024;20(33):2521-2531. doi: 10.1080/14796694.2024.2394013. Epub 2024 Sep 12.

    PubMed 39263892

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cisplatin, Gemcitabine and Nab-paclitaxel in people with Distal Bile Duct Adenocarcinoma and Gallbladder Carcinoma, run by City of Hope Medical Center at 1 site in United States.

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 28 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 3 Aug 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 6 weeks after cycle 1 (1 cycle = 21 days)). 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 NCT05285358, which also lists 1 linked publication.

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 3 Aug 2026.

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