At a glance
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A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)
In Brief
A Phase 2 clinical trial evaluating Bead Block microspheres and Bead + Dox Arm for Hepatocellular Carcinoma and 2 related conditions. Completed, enrolled 101 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.
Study Details
Timeline
Interventions
Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.