NCT05285358
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~12 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:CisplatinGemcitabineNab-paclitaxelQuality-of-Life AssessmentQuestionnaire Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 6 weeks after cycle 1 (1 cycle = 21 days)
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Daneng Li, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
- Mustafa Raoof, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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)
What this trial measures
- Incidence of adverse eventsUp 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.