Study Stopped
Slow enrollment
A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma
SOLACE
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
1 other identifier
interventional
2
1 country
6
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hepatocellular-carcinoma
Started Nov 2015
Shorter than P25 for phase_3 hepatocellular-carcinoma
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2017
CompletedResults Posted
Study results publicly available
November 8, 2017
CompletedFebruary 12, 2021
January 1, 2021
1.6 years
June 1, 2015
October 7, 2017
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival in HCC subjects with minimum follow-up of subjects to at least one year
1 year
Secondary Outcomes (4)
Time to Progression
2 years
Time to Extrahepatic Spread
2 years
Proportion Progression Free
1 year
Frequency of Treatment Emergent Adverse Events
2 years
Other Outcomes (2)
Proportion Achieved Tumor Response
2 years
FACT-Hep Quality of Life
2 years
Study Arms (2)
DEB-TACE
EXPERIMENTALONCO-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 COMPARATOR200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Interventions
Eligibility Criteria
You may qualify if:
- Written Informed Consent
- ≥18 years of age
- Diagnosis of HCC
- Locally advanced HCC
- Preserved liver function
- Eastern Cooperative Oncology Group 0 or 1
You may not qualify if:
- 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.
- 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:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Alabama Hospital
Birmingham, Alabama, 35233, United States
University of Southern California
Los Angeles, California, 90033, United States
University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The planned analyses were not performed due to early termination.
Results Point of Contact
- Title
- Kristi Winterfeldt
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Anastasia Becker
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 3, 2015
Study Start
November 1, 2015
Primary Completion
June 5, 2017
Study Completion
June 5, 2017
Last Updated
February 12, 2021
Results First Posted
November 8, 2017
Record last verified: 2021-01