Status:
TERMINATED
The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead
Lead Sponsor:
Washington University School of Medicine
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study involves the combined use of the FDA approved device, LC Bead and the FDA approved drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The current indication of t...
Detailed Description
Patients will be given IV fluids and premedication with 500 mg metronidazole, 10 mg dexamethasone, and 8 mg ondansetron to prevent infection, limit pain and nausea. The femoral artery will be accessed...
Eligibility Criteria
Inclusion
- Age \> 18
- Patent main portal vein with hepatopetal flow
- Bilirubin less than or equal to 2.5 mg/dl, albumin \>2.8g/dl, alkaline phosphatase \<630IU/L, AST \<235IU/L, ALT \<265IU/L, INR \<2.0, PTT \<40sec., absolute neutrophil count \>1K/cumm, platelet count \>100K/cumm
- No encephalopathy
- No previous biliary ductal intervention
- Child A status
- Confirmation of Hepatocellular Carcinoma (through biopsy or radiological exam)
- Unresectable HCC and ineligible for possible curative therapies
- Normal ECG with QT \<480 msec within the previous 2 months
- Normal MUGA scan within the previous 2 months
- Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST)
- Subject is competent and willing to provide written informed consent in order to participate in the study
Exclusion
- Thrombosis or hepatofugal flow in the main portal vein; presence of a large shunt which in the operator's opinion precludes embolization
- Replacement of greater than 50% of the liver parenchyma by tumor
- Bilirubin greater than or equal to 2.6 mg/dl
- ECOG performance status of 2 or greater
- Previous liver directed therapy
- Previous biliary intervention (excluding cholecystectomy)
- Allergy to iodinated contrast used for angiography
- Elevated creatinine greater than or equal to 1.8 mg/dl
- Women who are pregnant or nursing
- Patients in which any of the following are contraindicated: 1)the use of doxorubicin, 2)MRI or CT scans, 3) Hepatic embolization procedures
- Patients with active bacterial or fungal infection that is deemed to be clinically significant by the investigator
- Patients with cardiac disease, including congestive heart failure, recent myocardial infarction, or uncontrolled arrhythmias
- Non-English speaking patients
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01259024
Start Date
December 1 2011
End Date
April 1 2012
Last Update
May 15 2018
Active Locations (1)
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1
Barnes-Jewish Hospital/Washington Univesity School of Medicine
St Louis, Missouri, United States, 63110