Hepatocellular CarcinomaPhase 3SOLACENCT02460991
A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma
A Phase 3 study testing DEB-TACE and Sorafenib in people with Hepatocellular Carcinoma and Hepatoma, run by Boston Scientific Corporation at 6 sites in United States.
Trial summary
This is a prospective, multicenter study that will be conducted at up to 40 centers in the United States and Outside United States (OUS). Participants in the study will be randomly assigned to receive either ONCO-DOX or sorafenib treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma
- What is being tested?
- DEB-TACE and Sorafenib
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2015to 5 Jun 2017
- Phase
- Phase 3
- 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
- Written Informed Consent
- ≥18 years of age
- Diagnosis of HCC
- Locally advanced HCC
- Preserved liver function
- Eastern Cooperative Oncology Group 0 or 1
Who cannot join
- Presence of extra-hepatic spread of disease.
- Macrovascular invasion of lobar portal vein branches or main portal vein.
- Candidate for surgical resection, transplantation, or local ablation.
- Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.
- Any contraindication for TACE.
- Platelet count <50,000/mm3 or international normalized ratio >1.5.
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- Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.
- Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).
- Known ejection fraction < 50%.
- Current infections requiring antibiotic therapy.
- Suffering from a known bleeding disorder.
- Renal insufficiency (serum creatinine > 2 mg/dL).
- Aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal.
- Presence of advanced liver disease.
- Any contraindication for doxorubicin administration:
- Any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety.
- Patient has another primary tumor, with the exception of conventional basal cell carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
- Participation in a clinical trial of an investigational device or drug within 4 weeks of study entry.
- Pregnant or breast-feeding patients.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama Hospital
Birmingham, Alabama, 35233
MD Anderson Cancer Center
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
University of Louisville
Louisville, Kentucky, 40202
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized Controlled Trial of Transcatheter Arterial Chemoembolization With Drug Eluting Beads (DEB-TACE) Versus Sorafenib in the Treatment of Unresectable, Locally Advanced Hepatocellular Carcinoma
This is a prospective, multicenter study that will be conducted at up to 40 centers in the United States and Outside United States (OUS). Participants in the study will be randomly assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the study participants' outcomes (medical condition) after being treated with ONCO-DOX and compare it to those treated with sorafenib alone.
Read the detailed description
This is a prospective, two-arm, stratified then randomized (1:1), open label, controlled, multicenter Phase III trial to evaluate the safety and efficacy of ONCOZENE™ Microspheres loaded with doxorubicin (ONCO-DOX) in comparison with orally administered sorafenib in patients with unresectable, locally-advanced hepatocellular carcinoma (HCC).
Patients will be stratified by ECOG Performance Status 0 versus 1, portal vein invasion (yes vs. no), and alpha feto protein <400 versus ≥400. They will then be randomized at each site within each stratum.
The study will be conducted at up to 40 centers in the United States, Europe \& Asia. Enrolled patients will be randomized with equal allocation by study site.
Patients will be followed for two years after the onset of treatment.
The study will assess prospectively the efficacy and safety of DEB-TACE (ONCO-DOX) in patients with unresectable, locally-advanced HCC. The primary objective of this study is to compare the overall survival between DEB-TACE (ONCO-DOX) and sorafenib treatment groups.
- Conditions
- Hepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma
- Being tested
- DEB-TACE, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACEDevice
Also called ONCO-DOX
SorafenibDrug
Also called Nexavar
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE | Experimental | ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved. Receives: Device: DEB-TACE |
| Sorafenib | Active comparator | 200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival in HCC subjects with minimum follow-up of subjects to at least one year
Measured: 1 year
Secondary outcomes (4)
Time to Progression
Time to progression (TTP) determined by radiological assessment using mRECIST criteria
Measured: 2 years
Time to Extrahepatic Spread
Time to Extrahepatic Spread for each subject
Measured: 2 years
Proportion Progression Free
Proportion Progression-Free (PPF) at one year
Measured: 1 year
Frequency of Treatment Emergent Adverse Events
The frequency of treatment emergent adverse events at 30 day, 3, 6, 9, 12, 18, and 24-months following the initial treatment. The proportions of patients in each arm experiencing treatment emergent adverse events will be presented descriptively with the number experiencing the event, the number evaluated, the percentage, and the exact two-sided 95% confidence interval.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startNov 2015
- Primary completion5 Jun 2017
- Study completion5 Jun 2017
Why it stopped: Slow enrollment
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 Boston Scientific CorporationThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anastasia Becker, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460991
- Sponsor's protocol ID
- SOLACE
- Acronym
- SOLACE
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2015
- Last updated
- 12 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Transcatheter Arterial Chemoembolization With Drug Eluting Beads (DEB-TACE) Versus Sorafenib in the Treatment of Unresectable, Locally Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02460991
- Acronym / sponsor ID
- SOLACE / SOLACE
- Conditions
- Hepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 8 Nov 2017
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, multicenter study that will be conducted at up to 40 centers in the United States and Outside United States (OUS). Participants in the study will be randomly assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the study participants' outcomes (medical condition) after being treated with ONCO-DOX and compare it to those treated with sorafenib alone.
Detailed description
This is a prospective, two-arm, stratified then randomized (1:1), open label, controlled, multicenter Phase III trial to evaluate the safety and efficacy of ONCOZENE™ Microspheres loaded with doxorubicin (ONCO-DOX) in comparison with orally administered sorafenib in patients with unresectable, locally-advanced hepatocellular carcinoma (HCC).
Patients will be stratified by ECOG Performance Status 0 versus 1, portal vein invasion (yes vs. no), and alpha feto protein <400 versus ≥400. They will then be randomized at each site within each stratum.
The study will be conducted at up to 40 centers in the United States, Europe \& Asia. Enrolled patients will be randomized with equal allocation by study site.
Patients will be followed for two years after the onset of treatment.
The study will assess prospectively the efficacy and safety of DEB-TACE (ONCO-DOX) in patients with unresectable, locally-advanced HCC. The primary objective of this study is to compare the overall survival between DEB-TACE (ONCO-DOX) and sorafenib treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE | Experimental | Device: DEB-TACEONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved. |
| Sorafenib | Active comparator | Drug: Sorafenib200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written Informed Consent
- ≥18 years of age
- Diagnosis of HCC
- Locally advanced HCC
- Preserved liver function
Key exclusion criteria (19 listed)
- Presence of extra-hepatic spread of disease.
- Macrovascular invasion of lobar portal vein branches or main portal vein.
- Candidate for surgical resection, transplantation, or local ablation.
- Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.
- Any contraindication for TACE.
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 |
|---|---|---|
| DEB-TACEAlso: ONCO-DOX | Device | DEB-TACE |
| SorafenibAlso: Nexavar | Drug | Sorafenib |
Primary outcome
Overall Survival
Time frame: 1 year
Overall survival in HCC subjects with minimum follow-up of subjects to at least one year
4 secondary outcomes
Time to Progression
Time frame: 2 years
Time to Extrahepatic Spread
Time frame: 2 years
Proportion Progression Free
Time frame: 1 year
Frequency of Treatment Emergent Adverse Events
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- 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.
Anastasia Becker study director
Boston Scientific Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DEB-TACE and Sorafenib in people with Hepatocellular Carcinoma and Hepatoma, run by Boston Scientific Corporation at 6 sites 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 19 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 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Nov 2017). 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?
Overall Survival (time frame: 1 year). 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 12 Feb 2021.