NCT01489410

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

December 6, 2011

Last Update Submit

August 30, 2017

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Post-Embolization Syndrome

    Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.

    Week 6 Post Intervention

Secondary Outcomes (6)

  • Patients with Encephalopathy After Embolization

    Week 6 Post Intervention

  • Changes in Quality of Life

    Baseline and Week 6 After Intervention

  • Comparison of Liver Function Tests Results

    Day 0 and Week 6 Post Intervention

  • Imaging Response

    Week 6 Post Intervention

  • Number of Patients with Successful Liver Transplant

    Week 6 After Intervention

  • +1 more secondary outcomes

Study Arms (2)

Drug-Eluting Beads with Doxorubicin

ACTIVE COMPARATOR

Drug-Eluting Beads (DEB) with Doxorubicin is administered via beads that release it to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.

Drug: Drug-Eluting Beads (DEB) with Doxorubicin

Lipiodol Ethanol Mixture (LEM)

ACTIVE COMPARATOR

Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.

Drug: Lipiodol Ethanol Mixture

Interventions

Drug-Eluting Beads (DEB) with DoxorubicinDRUG

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).

Also known as: Doxorubicin
Drug-Eluting Beads with Doxorubicin
Lipiodol Ethanol MixtureDRUG

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).

Also known as: LEM
Lipiodol Ethanol Mixture (LEM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Erik Cressman, M.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 9, 2011

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

US(1)