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TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Primary Purpose

Liver Cancer, Portal Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TheraSphere
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Hepatocellular Carcinoma, portal vein thrombosis, HCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 yrs of age or older
  • Diagnosis of Hepatocellular Carcinoma
  • Portal Vein Thrombosis

  • ECOG performance < 2

    ->4 weeks since prior radiation, surgery or chemotherapy.

  • Life expectancy > 3 months
  • Able to provide written informed consent process in accordance with institutional review boards guidelines.

Exclusion Criteria:

  • Contraindications to angiography and selective visceral catheterization.
  • Evidence of blood flow to the lung from the liver greater than 16.5 mCi
  • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
  • Significant extrahepatic disease.
  • Severe liver disfunction of pulmonary insufficiency.
  • Active uncontrolled infection.
  • Significant underlying medical or psychiatric illness.
  • Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.

Sites / Locations

  • Emory University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therasphere

Arm Description

Outcomes

Primary Outcome Measures

Response rate to the administration of Therasphere

Secondary Outcome Measures

Progression free survival for patients with unresectable liver cancer.
Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.

Full Information

First Posted
February 13, 2012
Last Updated
May 23, 2014
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01556282
Brief Title
TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis
Official Title
A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.
Detailed Description
Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90. Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Portal Vein Thrombosis
Keywords
Hepatocellular Carcinoma, portal vein thrombosis, HCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therasphere
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TheraSphere
Other Intervention Name(s)
There are no other names for this device.
Intervention Description
TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
Primary Outcome Measure Information:
Title
Response rate to the administration of Therasphere
Time Frame
Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits
Secondary Outcome Measure Information:
Title
Progression free survival for patients with unresectable liver cancer.
Description
Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.
Time Frame
Participants will be followed through 1 year after receiving treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 yrs of age or older Diagnosis of Hepatocellular Carcinoma Portal Vein Thrombosis ECOG performance < 2 ->4 weeks since prior radiation, surgery or chemotherapy. Life expectancy > 3 months Able to provide written informed consent process in accordance with institutional review boards guidelines. Exclusion Criteria: Contraindications to angiography and selective visceral catheterization. Evidence of blood flow to the lung from the liver greater than 16.5 mCi Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow. Significant extrahepatic disease. Severe liver disfunction of pulmonary insufficiency. Active uncontrolled infection. Significant underlying medical or psychiatric illness. Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun s Kim, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29329568
Citation
Xing M, Kokabi N, Camacho JC, Kim HS. Prospective longitudinal quality of life and survival outcomes in patients with advanced infiltrative hepatocellular carcinoma and portal vein thrombosis treated with Yttrium-90 radioembolization. BMC Cancer. 2018 Jan 12;18(1):75. doi: 10.1186/s12885-017-3921-1.
Results Reference
derived
PubMed Identifier
25847227
Citation
Kokabi N, Camacho JC, Xing M, El-Rayes BF, Spivey JR, Knechtle SJ, Kim HS. Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis. Cancer. 2015 Jul 1;121(13):2164-74. doi: 10.1002/cncr.29275. Epub 2015 Apr 6.
Results Reference
derived

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TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

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