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

Recruiting Phase 1 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
City of Hope Medical Center · Other
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About This Trial
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 abdom…
Trial Locations
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Eligibility Criteria
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 m…
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