The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead
Primary Purpose
Hepatocellular Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transarterial chemoembolization using a drug-eluting bead
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, chemoembolization, transarterial chemoembolization, liver cancer, doxorubicin, drug-eluting beads, LC Bead
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Barnes-Jewish Hospital/Washington Univesity School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
doxorubicin-eluting LC Bead
Arm Description
transarterial chemoembolization using doxorubicin-eluting LC Beads
Outcomes
Primary Outcome Measures
To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Determine Efficacy (Based on Whether the Study is Positive or Negative) of the Embolization With the LC Bead in Treatment of HCC With Imaging Outcomes Using Modified RECIST and EASL Criteria.
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Monitor Safety After Treatment of DEB by Measuring Liver Function Tests and Assessing Performance Status.
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Secondary Outcome Measures
To Track Survival Following Treatment With DEB to Confirm That Any Gains in Response Are Associated With an Increase in Survival.
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Full Information
NCT ID
NCT01259024
First Posted
November 3, 2010
Last Updated
April 12, 2018
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01259024
Brief Title
The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead
Official Title
Hepatic Arterial Embolization of Hepatocellular Carcinoma With a Doxorubicin Eluting Bead
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
inability to obtain CMS approval
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 the LC Bead is for the embolization of hypervascular tumors and arteriovenous malformations. The study is designed to establish if drug eluting beads are more effective and less toxic than standard chemoembolization treatment.
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 and a catheter advanced into the superior mesenteric artery. Positioning of all catheters will be confirmed by injection of radiographic contrast material. Superior mesenteric angiography will be performed with images obtained through the portal venous phase to confirm patency and flow direction of the portal vein and determine the presence of aberrant supply to the right lobe of the liver by the superior mesenteric artery. The catheter will then be advanced into the celiac artery. Celiac angiography will be performed to determine remainder of the hepatic arterial anatomy. Selection of the tumor bearing artery will then be performed with a microcatheter which is advanced through the catheter in the celiac artery origin. Selection will be guided by fluoroscopy and will be at the lobar level or peripherally in all cases. Once the feeding vessel has been selected and confirmed by contrast injection, the physician will initiate embolization with LC Beads. Up to two vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared. The LC Beads will be mixed with radiographic contrast to ensure fluoroscopic visibility during injection. Under careful fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery reaches stasis prior to administration of both vials, the residual volume of LC Beads will be noted on the surgical report form. If after administration of the DEB, there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization. After confirming that the artery is appropriately treated, all catheters and guidewires will be removed from the femoral artery and hemostasis obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, chemoembolization, transarterial chemoembolization, liver cancer, doxorubicin, drug-eluting beads, LC Bead
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
doxorubicin-eluting LC Bead
Arm Type
Experimental
Arm Description
transarterial chemoembolization using doxorubicin-eluting LC Beads
Intervention Type
Device
Intervention Name(s)
transarterial chemoembolization using a drug-eluting bead
Other Intervention Name(s)
TACE, DEB TACE
Intervention Description
Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization.
Primary Outcome Measure Information:
Title
To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).
Description
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Time Frame
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
Title
Determine Efficacy (Based on Whether the Study is Positive or Negative) of the Embolization With the LC Bead in Treatment of HCC With Imaging Outcomes Using Modified RECIST and EASL Criteria.
Description
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Time Frame
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
Title
Monitor Safety After Treatment of DEB by Measuring Liver Function Tests and Assessing Performance Status.
Description
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Time Frame
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
Secondary Outcome Measure Information:
Title
To Track Survival Following Treatment With DEB to Confirm That Any Gains in Response Are Associated With an Increase in Survival.
Description
4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Time Frame
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nael E. Saad, M.D.
Organizational Affiliation
Mallinckrodt Institute of Radiology/Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital/Washington Univesity School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20213741
Citation
Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Comparison of conventional transarterial chemoembolization (TACE) and chemoembolization with doxorubicin drug eluting beads (DEB) for unresectable hepatocelluar carcinoma (HCC). J Surg Oncol. 2010 May 1;101(6):476-80. doi: 10.1002/jso.21522.
Results Reference
background
PubMed Identifier
16234031
Citation
Biselli M, Andreone P, Gramenzi A, Trevisani F, Cursaro C, Rossi C, Ricca Rosellini S, Camma C, Lorenzini S, Stefanini GF, Gasbarrini G, Bernardi M. Transcatheter arterial chemoembolization therapy for patients with hepatocellular carcinoma: a case-controlled study. Clin Gastroenterol Hepatol. 2005 Sep;3(9):918-25. doi: 10.1016/s1542-3565(05)00425-8.
Results Reference
background
PubMed Identifier
19937027
Citation
Malagari K, Pomoni M, Kelekis A, Pomoni A, Dourakis S, Spyridopoulos T, Moschouris H, Emmanouil E, Rizos S, Kelekis D. Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma. Cardiovasc Intervent Radiol. 2010 Jun;33(3):541-51. doi: 10.1007/s00270-009-9750-0. Epub 2009 Nov 24.
Results Reference
background
PubMed Identifier
20123210
Citation
Namur J, Wassef M, Millot JM, Lewis AL, Manfait M, Laurent A. Drug-eluting beads for liver embolization: concentration of doxorubicin in tissue and in beads in a pig model. J Vasc Interv Radiol. 2010 Feb;21(2):259-67. doi: 10.1016/j.jvir.2009.10.026. Erratum In: J Vasc Interv Radiol. 2010 Apr;21(4):596.
Results Reference
background
Links:
URL
http://www.medscape.com
Description
Interventional Radiological Treatment of Hepatocellular Carcinoma
URL
http://www.docguide.com
Description
Drug-Eluting Beads Significantly Reduce Doxorubicin Toxicity in Patients With HCC
URL
http://www.projectsinknowledge.com
Description
Efficacy of Drug-Eluting Beads in Chemoembolization of Hepatocellular Carcinoma
URL
http://www.biocompatibles.com
Description
Chemoembolization using Drug Eluting Beads is an effective procedure with a favourable pharmacokinetic profile
Learn more about this trial
The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead
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