Carcinoma, Hepatocellular Clinical Trial
Official title:
Study of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers (MTC-DOX) Administered by Intrahepatic Delivery Versus Intravenous Doxorubicin for Treatment of Patients With Unresectable Hepatocellular Carcinoma
MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to
magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is
added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and
deposited in the area of a tumor, where it is thought that it then "leaks" through the blood
vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free
from" the magnetic beads and will then be able to act against the tumor cells. The iron
component of the particle has magnetic properties, making it possible to direct MTC-DOX to
specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that
MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and
provide a treatment to patients with liver cancer.
To be sure of the effect of MTC-DOX on liver cancer, it will be compared to the effect of
Doxorubicin given through the vein.
The study treatments will be administered every three weeks, (which is considered a study
treatment cycle), until you complete six treatment cycles, the tumor grows, disappears, or
you experience a side effect, which may cause you to leave the study. Follow-up visits will
occur on Days 3, 10, and 21 following treatment in the first cycle and Days 7 and 21 for the
remaining cycles, and also 60 days after you receive your last treatment cycle.
Therefore, the purpose of this Phase 2/3 study is to evaluate safety, tolerance, and
efficacy (survival time) of an MTC-DOX dosing strategy where the DOX dose is determined by
tumor size
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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