TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma (TheraSphere)

January 4, 2024 updated by: Nadine Abi-Jaoudeh, University of California, Irvine

A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

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
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center

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

No

Description

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.

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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TheraSphere® treatment
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.
Device: TheraSphere
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate
Time Frame: 5 years
Percentage of people who are alive 5 years after receiving the treatment
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate for side effects
Time Frame: Every 1-2 months
Every 1-2 months

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Collaborators

BTG International Inc.

Investigators

  • Principal Investigator: Nadine Abi-Jaoudeh, MD, University of California, Irvine

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

May 8, 2002

Primary Completion

February 19, 2022

Study Completion

February 19, 2022

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimated)

May 21, 2009

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20022242
  • CA60396 (Other Grant/Funding Number: National Cancer Institute)
  • UCI 01-61 (Other Identifier: CFCCC)

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.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on TheraSphere

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe