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NCT02007954 · ClinicalTrials.gov registry record · Phase 2
Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT02007954: Completed Phase 2 study, sponsored by Yale University.
NCT02007954 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02007954, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE) DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive the smaller beads (DEBDOX), should it be recommended.
Primary Outcome
Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.
Interventions
- DEVICE DEBDOX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-11-18 |
| Phase | Phase 2 |
What the finished NCT02007954 record still lists
NCT02007954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which DEBDOX is the first listed.
NCT02007954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02007954 about?
NCT02007954 is a clinical study titled "Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma". The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with doxorubicin (DEBDOX-M1), and u...
What is the current status of trial NCT02007954?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2014-02. Estimated completion is 2016-11-18.
What interventions are being tested in trial NCT02007954?
The interventions under investigation include: DEBDOX (DEVICE).
Who is sponsoring clinical trial NCT02007954?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02007954's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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