Back to resultsA Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma (SOLACE)
Primary Purpose
Hepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DEB-TACE
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Written Informed Consent
- ≥18 years of age
- Diagnosis of HCC
- Locally advanced HCC
- Preserved liver function
- Eastern Cooperative Oncology Group 0 or 1
Exclusion Criteria:
- 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:
- 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.
Sites / Locations
- University of Alabama Hospital
- University of Southern California
- University of Louisville
- University of Maryland Medical Center
- Oregon Health & Science University
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DEB-TACE
Sorafenib
Arm Description
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.
200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Outcomes
Primary Outcome Measures
Overall Survival
Overall survival in HCC subjects with minimum follow-up of subjects to at least one year
Secondary Outcome Measures
Time to Progression
Time to progression (TTP) determined by radiological assessment using mRECIST criteria
Time to Extrahepatic Spread
Time to Extrahepatic Spread for each subject
Proportion Progression Free
Proportion Progression-Free (PPF) at one 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.
Full Information
NCT ID
NCT02460991
First Posted
June 1, 2015
Last Updated
January 25, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02460991
Brief Title
A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma
Acronym
SOLACE
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 5, 2017 (Actual)
Study Completion Date
June 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DEB-TACE
Arm Type
Experimental
Arm Description
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.
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Intervention Type
Device
Intervention Name(s)
DEB-TACE
Other Intervention Name(s)
ONCO-DOX
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival in HCC subjects with minimum follow-up of subjects to at least one year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to Progression
Description
Time to progression (TTP) determined by radiological assessment using mRECIST criteria
Time Frame
2 years
Title
Time to Extrahepatic Spread
Description
Time to Extrahepatic Spread for each subject
Time Frame
2 years
Title
Proportion Progression Free
Description
Proportion Progression-Free (PPF) at one year
Time Frame
1 year
Title
Frequency of Treatment Emergent Adverse Events
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Proportion Achieved Tumor Response
Description
The proportion of patients in each group that achieve complete response (CR), partial response (PR), and stable disease (SD) will be presented and compared across treatment groups.
Time Frame
2 years
Title
FACT-Hep Quality of Life
Description
FACT-Hep quality of life instrument validated in patients with Hepatic cancer.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written Informed Consent
≥18 years of age
Diagnosis of HCC
Locally advanced HCC
Preserved liver function
Eastern Cooperative Oncology Group 0 or 1
Exclusion Criteria:
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasia Becker
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma
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