Hepatocellular CarcinomaPhase 2HCCNCT00877071
LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed
A Phase 2 study testing LC Bead loaded with doxorubicin in people with Hepatocellular Carcinoma, run by University of Pittsburgh at 1 site in United States.
Trial summary
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. 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?
- LC Bead loaded with doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2012
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- HCC with gross vascular invasion or extrahepatic disease
- Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring dialysis
- Child-Pugh B9 or C hepatic impairment
- History of cardiac disease: NYHA class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
- Active clinically serious infections (> CTCAEv3 grade 2)
Show all 32Show fewer
- Known history of HIV
- Known central nervous system tumors including metastatic brain disease
- History of organ allograft
- Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Allergy to the investigational agents or any agent given in association with this trial.
- Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Any contraindication for doxorubicin administration:
- serum bilirubin > 3mg/dL
- WBC < 3000 cells/mm3
- neutrophil < 1500 cells/mm3
- cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or MRI
- MUGA scan < 40% ejection fraction
- Any contraindication for hepatic embolization procedures
- Excluded therapies and medications, previous and concomitant:
- Prior use of any systemic anti-cancer chemotherapy for HCC
- Prior use of any systemic investigational agents for HCC
- Major surgery within 6 weeks of start of study drug
- Radiotherapy during study or within 3 weeks prior to start of study drug
- Use of biological response modifiers such as granulocyte colony-stimulating factor (G-CSF)within 3 weeks prio to study entry
- Autologous bone marrow transplant or stem cell rescue within four months of study drug initiation
- Concomitant treatment with rifampin or St. John's wort
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Liver Cancer Center, Montefiore 7 South, 3459 Fifth Avenue
Pittsburgh, Pennsylvania, 15213
About this study
Official title: LC Drug Eluting Bead for Regional Chemoembolization to Downstage Unresectable Hepatocellular Carcinoma (HCC) to Liver Transplantation
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant.
Read the detailed description
LC BeadTM is a new product specifically designed for TACE. LC BeadTM microspheres can be loaded with doxorubicin (Trade name: adriamycin), a chemotherapeutic anthracycline glycolide agent widely accepted for treatment of HCC. This novel bead slowly releases the ionically bound chemotherapeutic agent rather than administering a bolus of chemotherapy as is the case with many alternative methods of TACE. Thus, the LC BeadTM offers the potential advantage of less toxicity and prolonged tumor exposure.
This study offers local regional therapy to a defined population of patients beyond transplant criteria as an attempt to downstage them to eligibility for liver transplantation. This study will make an important contribution to understanding the beads' local effect as seen in the explanted livers of those patients who go on to receive a liver transplant. Additionally, we will examine the impact of this novel treatment tool on patients' quality of life.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- LC Bead loaded with doxorubicin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC Bead loaded with doxorubicinDrug
Also called LC Bead
LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| LC Drug Eluting Bead, Regional Chemoembolization | Experimental | Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility Receives: Drug: LC Bead loaded with doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.
Measured: 36 months
Secondary outcomes (3)
The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria
Measured: 36 months
Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM
Measured: 36 months
The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2011
- Study completionApr 2012
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 PittsburghThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Principal investigator, David Geller, MD, University of Pittsburgh
- Investigators
- David A Geller, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877071
- Sponsor's protocol ID
- PRO08070016
- Acronym
- HCC
- Status last verified
- Feb 2016
- First submitted
- 4 Apr 2009
- Last updated
- 11 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LC Drug Eluting Bead for Regional Chemoembolization to Downstage Unresectable Hepatocellular Carcinoma (HCC) to Liver Transplantation
- ClinicalTrials.gov ID
- NCT00877071
- Acronym / sponsor ID
- HCC / PRO08070016
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Study start
- Nov 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Posted 8 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant.
Detailed description
LC BeadTM is a new product specifically designed for TACE. LC BeadTM microspheres can be loaded with doxorubicin (Trade name: adriamycin), a chemotherapeutic anthracycline glycolide agent widely accepted for treatment of HCC. This novel bead slowly releases the ionically bound chemotherapeutic agent rather than administering a bolus of chemotherapy as is the case with many alternative methods of TACE. Thus, the LC BeadTM offers the potential advantage of less toxicity and prolonged tumor exposure.
This study offers local regional therapy to a defined population of patients beyond transplant criteria as an attempt to downstage them to eligibility for liver transplantation. This study will make an important contribution to understanding the beads' local effect as seen in the explanted livers of those patients who go on to receive a liver transplant. Additionally, we will examine the impact of this novel treatment tool on patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LC Drug Eluting Bead, Regional Chemoembolization | Experimental | Drug: LC Bead loaded with doxorubicinUse of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- HCC with gross vascular invasion or extrahepatic disease
- Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring dialysis
- Child-Pugh B9 or C hepatic impairment
- History of cardiac disease: NYHA class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
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 |
|---|---|---|
| LC Bead loaded with doxorubicinAlso: LC BeadLC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation | Drug | LC Drug Eluting Bead, Regional Chemoembolization |
Primary outcome
The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM
Time frame: 36 months
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.
3 secondary outcomes
The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria
Time frame: 36 months
Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM
Time frame: 36 months
The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David A Geller, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LC Bead loaded with doxorubicin in people with Hepatocellular Carcinoma, run by University of Pittsburgh 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 0 inclusion and 32 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 11 Mar 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2016). 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?
The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM (time frame: 36 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 11 Mar 2016.