TACE is frequently offered to patients with baseline hepatic dysfunction with the purpose of diminishing hepatic tumor burden while patients await transplantation. Without this therapeutic measure, disease may progress beyond UNOS T2 criteria required for organ allocation. The purpose of the study is to determine whether transarterial chemoembolization using doxorubicin-eluting beads (DEB-TACE) can be used safely and effectively to treat patients with liver-only hepatocellular carcinoma (HCC) and baseline hepatic dysfunction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first.
University of California San Francisco
San Francisco, California, United States
Best Observed Radiographic Response Rate (Measured by mRECIST)
Best observed radiographic response rate to Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) was defined as number of patients who had CR, PR, or SD as their best observed response divided by total number of patients with at least one available CT or MRI. Definition of mRECIST for Hepatocellular Carcinoma (HCC). Complete response (CR) = Disappearance of any intratumoral arterial enhancement in all target lesions. Partial response (PR)=At least a 30% decrease in sum of diameters of viable (enhancement in arterial phase) target lesions, taking as reference baseline sum of diameters of target lesions. Stable disease (SD)=Any cases that do not qualify for either partial response or progressive disease. Progressive disease (PD)=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 (enh
Time frame: 1 year
Number of Patients Who Developed New Severe Adverse Events
Number of patients who developed new severe adverse events according to NCI CTCAE version 4.0
Time frame: 1 year
Best Observed Objective Radiographic Response by mRECIST
Best observed objective radiographic response was defined as the number of patients who had a complete response or partial response divided by total number of evaluable patients. Measured by mRECIST (see mRECIST definition in the description of the primary objective).
Time frame: 6 months
Time to Untreatable Progression (TTUP)
TTUP is defined as time (months) from the first on-study DEB-TACE to development of radiographic disease progression untreatable by liver-directed percutaneous or surgical methods (by mRECIST).
Time frame: 1 year
Time to Progression (TTP)
Time to progression was defined as the period of time from the first on-study DEB-TACE to radiographic disease progression at any site by mRECIST.
Time frame: 1 year
Time to Hepatic Progression (TTHP)
Time to hepatic progression (TTHP) was defined as a period of time from the first on-study DEB-TACE till development of radiographic evidence of disease progression in the liver by mRECIST.
Time frame: 1 year
Progression Free Survival (PFS) Rate
Progression free survival rate was defined as the number of patients who were alive and free from radiographic progression by mRECIST at pre-defined time periods. PFS rate was calculated at 3 months, 6 months, 12 months, and 24 months
Time frame: 3 months, 6 months, 12 Months, and 24 months
Proportion of Patients With Alpha-fetoprotein (AFP) Response With ≥ 50% Decline From Baseline
This measure was defined as the number of patients with alpha-fetoprotein (AFP) response with ≥ 50% decline from baseline (in patients with baseline level ≥ 20) after DEB-TACE.
Time frame: 1 year
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction (LVEF) was measured as percent contraction prior to the first DEB-TACE and 1 month following last planned DEB-TACE. Median LVEF and full range were reported.
Time frame: Baseline, 1 month following last planned DEB-TACE
Median Area Under Curve (AUC)
Area under curve for doxorubicin concentration in the serum over 7 days was measured by obtaining serum doxorubicin concentration samples at predose, 5 min, 20 min, 40 min, 60 min, 120 min, 6 hours, 24 hours, 7 days time points. A graph of serum doxorubicin concentration over time was then plotted for each of the 17 patients, and the area under the curve for each of the 17 patients was calculated. Pharmacokinetic sampling was performed only during each of the first planned DEB-TACE procedures.
Time frame: 7 days
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