The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead

April 12, 2018 updated by: Washington University School of Medicine

Hepatic Arterial Embolization of Hepatocellular Carcinoma With a Doxorubicin Eluting Bead

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital/Washington Univesity School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: doxorubicin-eluting LC Bead
transarterial chemoembolization using doxorubicin-eluting LC Beads
Device: transarterial chemoembolization using a drug-eluting bead
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.
Other Names:
  • TACE
  • DEB TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).
Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
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.
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
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.
Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
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.
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
Monitor Safety After Treatment of DEB by Measuring Liver Function Tests and Assessing Performance Status.
Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
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.
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Track Survival Following Treatment With DEB to Confirm That Any Gains in Response Are Associated With an Increase in Survival.
Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
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.
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Nael E. Saad, M.D., Mallinckrodt Institute of Radiology/Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 13, 2010

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201108256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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