This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™ Microspheres to treat hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Klinikum der Universitat Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, Germany
Klinikum Stuttgart- Katharinenhospital
Stuttgart, Baden-Wurttemberg, Germany
Klinikum Bogenhausen
München, Bavaria, Germany
Freedom From Serious Adverse Event (SAE) at 30days
Time frame: Up to 30 days
Freedom From Study Related SAE at 6 Months
Time frame: Up to 6 months
Freedom From Tumor Progression at 6 Months
Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Time frame: 6 months
12 Month Survival
Time frame: 12 months
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Kilinikum Darmstadt
Darmstadt, Hesse, Germany
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, Germany
University Hospital Regensburg
Regensburg, Germany