TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
April 28, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University
A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma
TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has been used to treat liver tumors.
When Y-90 is put into very tiny glass beads (TheraSphere), it can be injected into the liver through a blood vessel.
This allows a large local 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients present with disease that is not amenable to resection (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates.
The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional therapies for HCC may have several advantages over systemically administered treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than either therapeutic modality alone. TheraSphere may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.
Study Type
Observational
Enrollment (Actual)
474
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.
Description
Inclusion Criteria:
- Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver
- Patients who are able to give informed consent, will be eligible.
- Patients must have an ECOG Performance Status score of < or = 2
- Must have a life expectancy of > 3 months
- Non-pregnant with an acceptable contraception in premenopausal women
- Patients must be > 4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy
Exclusion Criteria:
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment of radiation to the lungs
- 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 (ex. placing catheter distal to gastric vessels)
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Severe liver dysfunction or 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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
TheraSphere
|
The target dose of TheraSphere most commonly used is 120 - 140 Gy.
Standard radiation safety techniques will be used.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response to Treatment
Time Frame: Through 24 months post-treatment
|
Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist.
The principal clinician will be able to get a preliminary evaluation of tumor response in patients who return for subsequent treatment, as part of the imaging studies required for repeat safety screening of patients.
|
Through 24 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety
Time Frame: Through 24 months post-treatment or death
|
Evaluate toxicities and adverse experiences associated with TheraSphere treatment
|
Through 24 months post-treatment or death
|
|
Survival Time
Time Frame: Through 24 months post-treatment or death
|
Evaluate survival time from the first treatment.
The disease status, survival and safety status of all patients who receive TheraSphere treatment will be evaluated annually until death or 2 years post-treatment.
In general, follow-up will be performed by the principal clinician.
In the event of patient death, the date and cause of death will be recorded in the medical record (if possible).
|
Through 24 months post-treatment or death
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Colette Shaw, MD, Thomas Jefferson University
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.
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
October 1, 2007
Primary Completion (Actual)
March 15, 2021
Study Completion (Actual)
March 15, 2021
Study Registration Dates
First Submitted
May 4, 2011
First Submitted That Met QC Criteria
May 5, 2011
First Posted (Estimated)
May 6, 2011
Study Record Updates
Last Update Posted (Actual)
April 29, 2025
Last Update Submitted That Met QC Criteria
April 28, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07D.366
- 2007-49 (Other Identifier: CCRRC)
- JT 1283 (Other Identifier: JeffTrial Number)
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.