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NCT05285358 · City of Hope Medical Center

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

What this study is about

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).

View original scientific description

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.

Interventions

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Nab-paclitaxel

Given via PIPAC

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Primary outcome measures

Incidence of adverse events

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

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

  • 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
  • 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)

Where

  • Duarte, California

Collaborators

National Cancer Institute (NCI)

Related conditions & keywords

Distal Bile Duct AdenocarcinomaGallbladder CarcinomaIntrahepatic CholangiocarcinomaMetastatic Malignant Neoplasm in the PeritoneumStage IV Distal Bile Duct Cancer AJCC v8Stage IV Intrahepatic Bile Duct Cancer AJCC v8Stage IV Intrahepatic Cholangiocarcinoma AJCC v8Stage IVB Gallbladder Cancer AJCC v8

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Aug 3, 2026 · Source of record for eligibility and locations

📊
1 of 12 participants interested
8% interest

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California

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Distal Bile Duct Adenocarcinoma Treatment Options in Duarte, California

If you're searching for Distal Bile Duct Adenocarcinoma treatment in Duarte, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Duarte and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Distal Bile Duct Adenocarcinoma. All study-related care is provided at no cost to participants.

Local Sites
1 locations in California
Now Enrolling
Up to 12 participants
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Why Consider a Clinical Trial for Distal Bile Duct Adenocarcinoma?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Distal Bile Duct Adenocarcinoma

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Distal Bile Duct Adenocarcinoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05285358. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.