OncoMatch/Clinical Trials/NCT05285358
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
Is NCT05285358 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cisplatin and Gemcitabine for distal bile duct adenocarcinoma.
Treatment: Cisplatin · Gemcitabine · Nab-paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Tumor Agnostic
Disease stage
Required: Stage IV, IVB (AJCC v8)
Metastatic disease required
Documented metastatic disease on computed tomography (CT) imaging or magnetic resonance imaging (MRI)... 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)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Any prior systemic therapy treatment for advanced cholangiocarcinoma or gallbladder cancer
Cannot have received: adjuvant therapy
Exception: completed >= 6 months prior to registration
Any prior adjuvant therapy (chemotherapy, radiation therapy, biological therapy, immunotherapy) completed < 6 months prior to registration
Lab requirements
Blood counts
ANC >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin >= 8 g/dL
Kidney function
Calculated creatinine clearance of >= 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 X ULN (unless has Gilbert's disease, then direct bilirubin < 1.5 mg/dL); AST <= 5 x ULN; ALT <= 5 x ULN; serum albumin >= 2.8 g/dL
ANC >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin >= 8 g/dL; Serum albumin >= 2.8 g/dL; Total bilirubin <= 1.5 X ULN (unless has Gilbert's disease, then direct bilirubin < 1.5 mg/dL); AST <= 5 x ULN; ALT <= 5 x ULN; Calculated creatinine clearance of >= 45 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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