Liver CancerNCT01556282
TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis
A study testing TheraSphere in people with Liver Cancer and Portal Vein Thrombosis, run by Emory University at 1 site in United States.
Trial summary
Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Portal Vein Thrombosis
- What is being tested?
- TheraSphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2014
- Phase
- Interventional
- 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
Who may be able to join
- 18 yrs of age or older
- Diagnosis of Hepatocellular Carcinoma
- Portal Vein Thrombosis
- ECOG performance < 2
- ->4 weeks since prior radiation, surgery or chemotherapy.
- Life expectancy > 3 months
- Able to provide written informed consent process in accordance with institutional review boards guidelines.
Who cannot join
- Contraindications to angiography and selective visceral catheterization.
- Evidence of blood flow to the lung from the liver greater than 16.5 mCi
- 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.
- Significant extrahepatic disease.
- Severe liver disfunction of 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis
Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.
Read the detailed description
Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.
Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.
- Conditions
- Liver Cancer, Portal Vein Thrombosis
- Being tested
- TheraSphere
- Keywords
- Hepatocellular Carcinoma, portal vein thrombosis, HCC
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphereDevice
Also called There are no other names for this device.
TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
| Study group | Role | What they receive |
|---|---|---|
| Therasphere | Experimental | Not described Receives: Device: TheraSphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to the administration of Therasphere
Measured: Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits
Secondary outcomes (1)
Progression free survival for patients with unresectable liver cancer.
Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.
Measured: Participants will be followed through 1 year after receiving treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Kevin Kim, Emory University
- Investigators
- Hyun s Kim, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556282
- Sponsor's protocol ID
- IRB00015167
- Status last verified
- May 2014
- First submitted
- 13 Feb 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Xing M, Kokabi N, Camacho JC, Kim HS. Prospective longitudinal quality of life and survival outcomes in patients with advanced infiltrative hepatocellular carcinoma and portal vein thrombosis treated with Yttrium-90 radioembolization. BMC Cancer. 2018 Jan 12;18(1):75. doi: 10.1186/s12885-017-3921-1.
PubMed 29329568Kokabi N, Camacho JC, Xing M, El-Rayes BF, Spivey JR, Knechtle SJ, Kim HS. Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis. Cancer. 2015 Jul 1;121(13):2164-74. doi: 10.1002/cncr.29275. Epub 2015 Apr 6.
PubMed 25847227
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT01556282
- Acronym / sponsor ID
- IRB00015167
- Conditions
- Liver Cancer, Portal Vein Thrombosis
- Keywords
- Hepatocellular Carcinoma, portal vein thrombosis, HCC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Mar 2012 (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 will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.
Detailed description
Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.
Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therasphere | Experimental | Device: TheraSphere |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 yrs of age or older
- Diagnosis of Hepatocellular Carcinoma
- Portal Vein Thrombosis
- ECOG performance < 2
- ->4 weeks since prior radiation, surgery or chemotherapy.
Key exclusion criteria (8 listed)
- Contraindications to angiography and selective visceral catheterization.
- Evidence of blood flow to the lung from the liver greater than 16.5 mCi
- 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.
- Significant extrahepatic disease.
- Severe liver disfunction of 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: There are no other names for this device.TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel. | Device | Therasphere |
Primary outcome
Response rate to the administration of Therasphere
Time frame: Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits
1 secondary outcome
Progression free survival for patients with unresectable liver cancer.
Time frame: Participants will be followed through 1 year after receiving treatment
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 28 May 2014.
- Derived from this study: PubMed 29329568Xing M, Kokabi N, Camacho JC, Kim HS. Prospective longitudinal quality of life and survival outcomes in patients with advanced infiltrative hepatocellular carcinoma and portal vein thrombosis treated with Yttrium-90 radioembolization. BMC Cancer. 2018 Jan 12;18(1):75. doi: 10.1186/s12885-017-3921-1.
- Derived from this study: PubMed 25847227Kokabi N, Camacho JC, Xing M, El-Rayes BF, Spivey JR, Knechtle SJ, Kim HS. Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis. Cancer. 2015 Jul 1;121(13):2164-74. doi: 10.1002/cncr.29275. Epub 2015 Apr 6.
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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.
Hyun s Kim, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSphere in people with Liver Cancer and Portal Vein Thrombosis, run by Emory 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 7 inclusion and 8 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 28 May 2014. 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 rate to the administration of Therasphere (time frame: Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556282, which also lists 2 linked publications.
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 28 May 2014.