Actively Recruiting
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
Led by City of Hope Medical Center · Updated on 2026-03-13
12
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial 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). 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.
CONDITIONS
Official Title
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and assent if appropriate
- Age 18 years or older
- ECOG performance status of 0 or 1
- Confirmed diagnosis of intrahepatic or extrahepatic cholangiocarcinoma or gallbladder cancer
- Documented metastatic disease on CT or MRI within 28 days prior to registration
- Visible peritoneal metastases on imaging or diagnostic laparoscopy
- Fully recovered from prior anti-cancer therapy side effects except minor ones
- Complete medical history and physical exam within 28 days prior to treatment
- Adequate blood counts and organ function within 28 days prior to treatment
- Seronegative or controlled HIV infection
- Documented hepatitis virology status with controlled viral loads if positive
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain during study and for 14 months after
You will not qualify if you...
- Prior systemic therapy for advanced cholangiocarcinoma or gallbladder cancer
- Prior adjuvant therapy completed less than 6 months before registration
- Use of strong CYP3A4 inducers/inhibitors within 14 days before treatment
- Bowel obstruction requiring special feeding or drainage
- Liver metastases occupying 50% or more of the liver
- History or presence of brain or subdural metastases
- Life expectancy less than 3 months
- Peripheral neuropathy grade 2 or higher
- Recent therapeutic antibiotics use within 14 days before treatment
- Prior malignancy except certain treated cancers in remission
- Allergic reactions to similar chemotherapy agents
- Significant uncontrolled illnesses
- Pregnant or breastfeeding women
- Conditions or limitations preventing compliance with study procedures as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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