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NCT04891289 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
A Phase 2 study of Intrahepatic Cholangiocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
- 11
- Study locations
NCT04891289: Recruiting Phase 2 study of Intrahepatic Cholangiocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04891289 is a Phase 2 study of Intrahepatic Cholangiocarcinoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 164 participants, above the 126-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (30% higher). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04891289, a Phase 2 study of Intrahepatic Cholangiocarcinoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
- 11
- Study locations
Study Summary
This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.
Primary Outcome
will be done using RECIST (version 1.1).
Conditions Studied
Interventions
- DRUG Oxaliplatin
- DRUG Dexamethasone
- DRUG Gemcitabine
- DRUG Floxuridine (FUDR)
- DEVICE Implanted Medical Device
Study Locations (11)
New York
- Memorial Sloan Kettering Commack - Limited Protocol Activities - Commack
- Memorial Sloan Kettering Westchester - Limited Protocol Activities - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Limited Protocol Activities - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities - Basking Ridge
- Memorial Sloan Kettering Monmouth - Limited Protocol Activities - Middletown
- Memorial Sloan Kettering Bergen - Limited Protocol Activities - Montvale
Maryland
- National Heart, Lung, and Blood Institute (NIH) (Data Collection Only) - Bethesda
Missouri
- Washington University (Data Collection Only) - St Louis
North Carolina
- Duke University (Data Collection Only) - Durham
Other
- Erasmus University (Data Collection Only) - Rotterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2021-05-07 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT04891289 shows while recruiting
NCT04891289 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT04891289 lists 11 locations in 6 states (New York, New Jersey, Maryland).
Frequently Asked Questions
What is clinical trial NCT04891289 about?
NCT04891289 is a clinical study titled "Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery". This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to fin...
What is the current status of trial NCT04891289?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2021-05-07. Estimated completion is 2026-05.
What conditions does trial NCT04891289 study?
This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma.
What interventions are being tested in trial NCT04891289?
The interventions under investigation include: Oxaliplatin (DRUG), Dexamethasone (DRUG), Gemcitabine (DRUG), Floxuridine (FUDR) (DRUG), Implanted Medical Device (DEVICE).
Who is sponsoring clinical trial NCT04891289?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04891289 being conducted?
This trial has 11 study locations across Maryland, Missouri, New Jersey, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04891289's enrollment target sits among peer trials
164 6th of 17 higher than 12 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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