Colorectal Carcinoma Clinical Trial
Official title:
Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy: A Pilot Study of Irinotecan in the Treatment of Metastatic Colorectal Carcinoma (mCRC) by Embozene TANDEM™ Drug-Eluting Microspheres Embolization
The purpose of this study is to determine safety and local tumor control of Embozene TANDEM Microspheres (40um TANDEM) loaded with Irinotecan to treat metastatic colorectal carcinoma (mCRC).
Colon or rectal carcinoma that has spread to the liver is considered to be metastatic and is
a Stage IV cancer. If the metastasized tumor is unresectable, the only current treatment is
chemotherapy. Transarterial Chemoembolization (TACE) is considered as a palliative treatment
in advanced metastatic colorectal carcinoma (mCRC), with the potential of local tumor
control. TACE has evolved in the past 8 years to include drug-delivery devices that can
target and deliver drugs from small microparticles (DEB-TACE). Superselective DEB-TACE has
the potential to penetrate deeper into the tumor's vasculature to reach peripheral growing
points. Loading these microparticles with a cytotoxic drug may improve the level of local
tumor control.
The MIRACLE III study is a controlled, pilot, single center (Italy) study on 18 subjects with
pretreated non-resectable mCRC.
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