A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma (SOLACE)

• ClinicalTrials.gov Identifier: NCT02460991
• Recruitment Status: Terminated
• First Posted: June 3, 2015
• Results First Posted: November 8, 2017
• Last Update Posted: February 12, 2021
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

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.

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma; Hepatoma; Liver Cell Carcinoma	Device: DEB-TACE; Drug: Sorafenib	Phase 3

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: June 5, 2017
• Actual Study Completion Date: June 5, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: DEB-TACE; 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.	Device: DEB-TACE; Other Name: ONCO-DOX
Active Comparator: Sorafenib; 200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression	Drug: Sorafenib; Other Name: Nexavar

Outcome Measures

Primary Outcome Measures :

1. Overall Survival [ Time Frame: 1 year ]
   Overall survival in HCC subjects with minimum follow-up of subjects to at least one year

Secondary Outcome Measures :

1. Time to Progression [ Time Frame: 2 years ]
   Time to progression (TTP) determined by radiological assessment using mRECIST criteria
2. Time to Extrahepatic Spread [ Time Frame: 2 years ]
   Time to Extrahepatic Spread for each subject
3. Proportion Progression Free [ Time Frame: 1 year ]
   Proportion Progression-Free (PPF) at one year
4. Frequency of Treatment Emergent Adverse Events [ Time Frame: 2 years ]
   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.

Other Outcome Measures:

1. Proportion Achieved Tumor Response [ Time Frame: 2 years ]
   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.
2. FACT-Hep Quality of Life [ Time Frame: 2 years ]
   FACT-Hep quality of life instrument validated in patients with Hepatic cancer.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Written Informed Consent
2. ≥18 years of age
3. Diagnosis of HCC
4. Locally advanced HCC
5. Preserved liver function
6. Eastern Cooperative Oncology Group 0 or 1

Exclusion Criteria:

1. Presence of extra-hepatic spread of disease.
2. Macrovascular invasion of lobar portal vein branches or main portal vein.
3. Candidate for surgical resection, transplantation, or local ablation.
4. Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.
5. Any contraindication for TACE.
6. Platelet count <50,000/mm3 or international normalized ratio >1.5.
7. Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.
8. Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).
9. Known ejection fraction < 50%.
10. Current infections requiring antibiotic therapy.
11. Suffering from a known bleeding disorder.
12. Renal insufficiency (serum creatinine > 2 mg/dL).
13. Aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal.
14. Presence of advanced liver disease.
15. Any contraindication for doxorubicin administration:
16. 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.
17. 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
18. Participation in a clinical trial of an investigational device or drug within 4 weeks of study entry.
19. Pregnant or breast-feeding patients.

Contacts and Locations

Locations

United States, Alabama

University of Alabama Hospital

Birmingham, Alabama, United States, 35233

United States, California

University of Southern California

Los Angeles, California, United States, 90033

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

United States, Maryland

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Study Director: Anastasia Becker; Boston Scientific Corporation

  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] May 15, 2015

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02460991
• Other Study ID Numbers: SOLACE
• First Posted: June 3, 2015
• Results First Posted: November 8, 2017
• Last Update Posted: February 12, 2021
• Last Verified: January 2021

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Sorafenib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action