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NCT05285358 · ClinicalTrials.gov registry record · Phase 1
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases
A Phase 1 study of Intrahepatic Cholangiocarcinoma and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05285358 is a Phase 1 study of Intrahepatic Cholangiocarcinoma and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 12 participants, below the 135-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05285358, a Phase 1 study of Intrahepatic Cholangiocarcinoma and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Cisplatin
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2028-10-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05285358
The ClinicalTrials.gov registry entry for NCT05285358 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (91% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT05285358 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05285358 about?
NCT05285358 is a clinical study titled "Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases". 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 admini...
What is the current status of trial NCT05285358?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-09-19. Estimated completion is 2028-10-11.
What conditions does trial NCT05285358 study?
This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Metastatic Malignant Neoplasm in the Peritoneum, Gallbladder Carcinoma, Stage IV Distal Bile Duct Cancer AJCC v8.
What interventions are being tested in trial NCT05285358?
The interventions under investigation include: Cisplatin (DRUG), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Gemcitabine (DRUG), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT05285358?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05285358 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.