Hepatocellular Carcinoma
Conditions
Brief summary
Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.
Detailed description
This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin (DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM, which if true will facilitate a simple alternative to DEBs. Patients will be randomized to one arm of the study and will remain in that arm if they need to have more embolization in the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.
Interventions
DRUGDrug-Eluting Beads (DEB) with Doxorubicin
One treatment of Drug-Eluting Beads (DEB) with Doxorubicin administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).
DRUGLipiodol Ethanol Mixture
One treatment of Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Child-Pugh class A or B * Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria * Patient not a candidate for surgical resection or percutaneous ablation * age \> 18 years old and able to consent
Exclusion criteria
* Child-Pugh class C * Model for End-Stage Liver Disease (MELD) score \>16 * Extrahepatic disease * Bilateral or main portal vein thrombus * Total bilirubin \> 2.2 * Serum albumin \< 2.6 * Life expectancy \< 2 months * Uncorrected INR \> 2 * Eastern Cooperative Oncology Group (ECOG) status \> 2 * Tumor burden \> 50% liver volume * Hepatofugal portal venous flow
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients with Post-Embolization Syndrome | Week 6 Post Intervention | Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Quality of Life | Baseline and Week 6 After Intervention | Changes (noted as a score of 0 \[not at all\] to 4 \[very much\]; total score ranges from 1-180) in the different aspects of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) quality of life questionnaire (a 45-item self-report instrument designed to measure health-related quality of life in patients with hepatobiliary cancers). |
| Comparison of Liver Function Tests Results | Day 0 and Week 6 Post Intervention | List of results for alpha-fetoprotein (AFP), albumin (Alb), alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), blood urea nitrogen (BUN), creatinine (Cr), glomerular filtration rate (GFR), Bilirubin (T, D), platelets (Plt), international normalized ratio (INR - prothrombin time), Child-Pugh score. |
| Patients with Encephalopathy After Embolization | Week 6 Post Intervention | Count of patients who had encephalopathy after embolization. |
| Number of Patients with Successful Liver Transplant | Week 6 After Intervention | — |
| Overall Survival | Week 6 After Intervention | Determined by date of death or date censored. |
| Imaging Response | Week 6 Post Intervention | Determined by European Association for the Study of the Liver (EASL) criteria a set of non-invasive criteria for HCC in cirrhotic patients. The diagnosis is established if two imaging modalities (US, CT, magnetic resonance imaging (MRI)) show a coincidental nodule with arterial hypervascularization regardless of AFP levels, or if a single modality shows a lesion when the AFP levels are more than 400 ng/ml. Histologic diagnosis is required if the patient is non-cirrhotic or if the lesions are smaller than 2 cm. |
Countries
United States
Outcome results
None listed