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TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma (TheraSphere)

Primary Purpose

Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm

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

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Liver cancer, Primary liver cancer, Unresectable liver cancer, Unresectable hepatocellular carcinoma, TheraSphere

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed diagnosis of intrahepatic carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as Alpha-fetoprotein assay (AFP) (clinical diagnosis).
  • The cancer must be unresectable.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
  • Age ≥ 18 years.
  • Able to comprehend and read the study information sheet in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Any pre-treatment laboratory findings within 15 days of treatment demonstrating:

    • Absolute granulocyte count ≤ 1,500/ul
    • Platelet count ≤ 75,000/μl
    • Serum creatinine ≥ 2.0 mg/dl
    • Serum bilirubin ≥ 2.0 mg/dl

  • Any of the following contraindications to angiography and selective visceral catheterization:

    • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
    • Bleeding diathesis, not correctable by usual forms of therapy
    • Severe peripheral vascular disease that would preclude catheterization.
  • Portal hypertension with portal venous shunt away from the liver.
  • Evidence of potential delivery of greater than 16.5 millicurie (mCi) (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
  • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
  • Significant extrahepatic disease representing an imminent life-threatening outcome.
  • Severe liver dysfunction or pulmonary insufficiency.
  • Active uncontrolled infection.
  • Significant underlying medical or psychiatric illness.
  • Pregnant women may not participate.

Sites / Locations

  • Chao Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TheraSphere® treatment

Arm Description

TheraSphere® treatment will be performed in the outpatient setting. The effect on the tumor and any side effects of TheraSphere® HUD treatment will be examined. This is not a research study and there are no comparison or experimental treatments being used. Within 14 days of initial treatment, reverification of eligibility will be confirmed. If review of eligibility indicates an uncorrectable risk of flow to the gastrointestinal organs or risk of shunting to the lungs, treatment will not be administered. In this event, the patient will receive alternative treatment (chemoembolization) or no treatment. If the patient remains eligible, TheraSphere® will be administered within 14 days. All patients will be evaluated at 30 days post-treatment to assess clinical experience and adverse effects. Subsequently, patient status will be followed via communication with the referring oncologist to determine disease status and survival. Survival surveillance will continue up to 24 months.

Outcomes

Primary Outcome Measures

Overall Survival Rate
Percentage of people who are alive 5 years after receiving the treatment

Secondary Outcome Measures

Full Information

First Posted
December 27, 2007
Last Updated
May 2, 2023
Sponsor
University of California, Irvine
Collaborators
BTG International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00906984
Brief Title
TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
Acronym
TheraSphere
Official Title
A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2002 (Actual)
Primary Completion Date
February 19, 2022 (Actual)
Study Completion Date
February 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
BTG International Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this protocol is to provide TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. The effect on the tumor and any side effects of TheraSphere treatment will be examined. This study will provide supervised and limited access to TheraSphere treatment at University California Irvine Medical Center. TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. When Y-90 is incorporated into very tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels supplying the liver. This allows a large dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. The radiation from TheraSphere is contained within the body and becomes minimally active within 7 days after treatment due to physical decay. The glass beads remain in the body, but do not cause any health problems. TheraSphere has been approved for use in the treatment of liver cancer in the United States by the Food and Drug Administration on a limited basis.
Detailed Description
This protocol provides TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. Patients with hepatocellular carcinoma will be evaluated for eligibility for this treatment with the following: physical examination, medical history, blood tests requiring approximately 2 tablespoons of blood, EKG, CT or MR of chest to examine lungs, CT or magnetic resonance (MR) of abdomen to evaluate liver, stomach and intestines, and bone scan to rule out spread of disease to bones. If eligible on initial screening, patients will proceed to a second stage of screening, including an hepatic angiogram to confirm treatment can be provided safely and to highlight the blood vessels supplying the liver, and a nuclear medicine study (Tc-99m MAA scan) to display the blood flow to the lungs, stomach and intestines. When it is determined treatment can be delivered safely, patients will receive TheraSphere via the hepatic artery through blood vessels supplying the liver on an outpatient basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm, Primary Liver Cancer
Keywords
Hepatocellular carcinoma, Liver cancer, Primary liver cancer, Unresectable liver cancer, Unresectable hepatocellular carcinoma, TheraSphere

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TheraSphere® treatment
Arm Type
Other
Arm Description
TheraSphere® treatment will be performed in the outpatient setting. The effect on the tumor and any side effects of TheraSphere® HUD treatment will be examined. This is not a research study and there are no comparison or experimental treatments being used. Within 14 days of initial treatment, reverification of eligibility will be confirmed. If review of eligibility indicates an uncorrectable risk of flow to the gastrointestinal organs or risk of shunting to the lungs, treatment will not be administered. In this event, the patient will receive alternative treatment (chemoembolization) or no treatment. If the patient remains eligible, TheraSphere® will be administered within 14 days. All patients will be evaluated at 30 days post-treatment to assess clinical experience and adverse effects. Subsequently, patient status will be followed via communication with the referring oncologist to determine disease status and survival. Survival surveillance will continue up to 24 months.
Intervention Type
Device
Intervention Name(s)
TheraSphere
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall Survival Rate
Description
Percentage of people who are alive 5 years after receiving the treatment
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of intrahepatic carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as Alpha-fetoprotein assay (AFP) (clinical diagnosis). The cancer must be unresectable. Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2 Age ≥ 18 years. Able to comprehend and read the study information sheet in accordance with institutional and federal guidelines. Exclusion Criteria: Any pre-treatment laboratory findings within 15 days of treatment demonstrating: Absolute granulocyte count ≤ 1,500/ul Platelet count ≤ 75,000/μl Serum creatinine ≥ 2.0 mg/dl Serum bilirubin ≥ 2.0 mg/dl Any of the following contraindications to angiography and selective visceral catheterization: History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine Bleeding diathesis, not correctable by usual forms of therapy Severe peripheral vascular disease that would preclude catheterization. Portal hypertension with portal venous shunt away from the liver. Evidence of potential delivery of greater than 16.5 millicurie (mCi) (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments. Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. Significant extrahepatic disease representing an imminent life-threatening outcome. Severe liver dysfunction or pulmonary insufficiency. Active uncontrolled infection. Significant underlying medical or psychiatric illness. Pregnant women may not participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Abi-Jaoudeh, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16923973
Citation
Salem R, Thurston KG. Radioembolization with 90Yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 1: Technical and methodologic considerations. J Vasc Interv Radiol. 2006 Aug;17(8):1251-78. doi: 10.1097/01.RVI.0000233785.75257.9A. Erratum In: J Vasc Interv Radiol. 2006 Oct;17(10):1594.
Results Reference
background
PubMed Identifier
16990462
Citation
Salem R, Thurston KG. Radioembolization with 90yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 2: special topics. J Vasc Interv Radiol. 2006 Sep;17(9):1425-39. doi: 10.1097/01.RVI.0000235779.88652.53.
Results Reference
background
PubMed Identifier
17056999
Citation
Salem R, Thurston KG. Radioembolization with yttrium-90 microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 3: comprehensive literature review and future direction. J Vasc Interv Radiol. 2006 Oct;17(10):1571-93. doi: 10.1097/01.RVI.0000236744.34720.73.
Results Reference
background
Links:
URL
http://www.therasphere.com
Description
More information on TheraSphere

Learn more about this trial

TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

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