Hepatocellular CarcinomaNCT01349075
TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TheraSphere
- Type of treatment
- Surgery or procedure
- How many people
- 474 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TheraSphere
- Keywords
- Unresectable, Hepatocellular Carcinoma, TheraSphere, Yttrium-90
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphereRadiation
Also called Yttrium-90
The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used.
| Study group | Role | What they receive |
|---|---|---|
| TheraSphere | Not described Receives: Radiation: TheraSphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to 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.
Measured: Through 24 months post-treatment
Secondary outcomes (2)
Safety
Evaluate toxicities and adverse experiences associated with TheraSphere treatment
Measured: Through 24 months post-treatment or death
Survival Time
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).
Measured: Through 24 months post-treatment or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startOct 2007
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colette Shaw, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349075
- Sponsor's protocol ID
- 07D.366
- Other IDs
- 2007-49, JT 1283
- Status last verified
- Apr 2025
- First submitted
- 4 May 2011
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01349075
- Acronym / sponsor ID
- 07D.366
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Unresectable, Hepatocellular Carcinoma, TheraSphere, Yttrium-90
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TheraSphere | – | Radiation: TheraSphere |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSphereAlso: Yttrium-90The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used. | Radiation | TheraSphere |
Primary outcome
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.
2 secondary outcomes
Safety
Time frame: Through 24 months post-treatment or death
Survival Time
Time frame: Through 24 months post-treatment or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colette Shaw, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to Treatment (time frame: Through 24 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.