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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: Recruiting Phase 1 study of Intrahepatic Cholangiocarcinoma and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by City of Hope Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT05285358 shows while recruiting
NCT05285358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 135-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05285358's enrollment target sits among peer trials
12 17th of 17 higher than 1 of 17 other Intrahepatic Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intrahepatic Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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