Hepatocellular CarcinomaNCT01290523
Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma
A study testing Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) in people with Hepatocellular Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®). 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?
- Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- The cancer is unresectable.
- All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Age 18 years or older.
- Able to understand informed consent.
Who cannot join
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
- single TheraSphere administration; or
- cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
- Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
- Previous radiation therapy to the lungs and/or to the upper abdomen
- Pregnancy
Show all 15Show fewer
- Symptomatic lung disease.
- Significant extrahepatic disease representing an imminent life-threatening outcome.
- Active uncontrolled infection
- Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
- Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
- Serum bilirubin greater than 2 mg/dl
- Infiltrative tumor on imaging
- Tumor volume greater than 70% of liver volume
- Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study
This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)Device
Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
| Study group | Role | What they receive |
|---|---|---|
| Yttrium-90 liver radioembolization | Experimental | Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Receives: Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain
Measured: 6 months
Secondary outcomes (1)
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT:
up to 5 lesions at baseline and sum longest diameters (SLD).
- Complete Response (CR), -Target Lesions: Disappearance of all target lesions. -Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level.
- Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;
- Stable Disease (SD) < %30 decrease in the sum of the longest diameter of target lesions.
- Progressive Disease (PD) -Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Off study clinical use of Y90 glass microspheres (TheraSphere)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Fidelman, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290523
- Sponsor's protocol ID
- UCSF-SIRT-HCC
- Status last verified
- Apr 2019
- First submitted
- 1 Feb 2011
- Last updated
- 13 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT01290523
- Acronym / sponsor ID
- UCSF-SIRT-HCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Off study clinical use of Y90 glass microspheres (TheraSphere)
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 25 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yttrium-90 liver radioembolization | Experimental | Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- The cancer is unresectable.
- All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Age 18 years or older.
Key exclusion criteria (15 listed)
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
- Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
- Previous radiation therapy to the lungs and/or to the upper abdomen
- Pregnancy
- Symptomatic lung disease.
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 |
|---|---|---|
| Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery | Device | Yttrium-90 liver radioembolization |
Primary outcome
Number of Participants With Adverse Events
Time frame: 6 months
Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain
1 secondary outcome
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Nicholas Fidelman, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) in people with Hepatocellular Carcinoma, run by University of California, San Francisco 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 15 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: stopped early, as of the sponsor's last update on 13 May 2019. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (time frame: 6 months). 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 13 May 2019.