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

Recruiting now · Phase 1

Conditions studied: Distal Bile Duct Adenocarcinoma, Gallbladder Carcinoma, Intrahepatic Cholangiocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Intrahepatic Bile Duct Cancer AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Stage IVB Gallbladder Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT05285358
Run by: City of Hope Medical Center
People needed: 12
Starts: 2022-09-19
Expected to finish: 2028-10-11
Last updated by the study team: 2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 it is running

City of Hope Medical Center — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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