A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02460991
• Other study ID #: SOLACE
• Status: Terminated
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: June 5, 2017

Study information

• Verified date: January 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 5, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatoma
• Liver Cell Carcinoma

Intervention

Device:
• DEB-TACE

Drug:
• Sorafenib

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama Hospital	Birmingham	Alabama
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion Achieved Tumor Response	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 years
Other	FACT-Hep Quality of Life	FACT-Hep quality of life instrument validated in patients with Hepatic cancer.	2 years
Primary	Overall Survival	Overall survival in HCC subjects with minimum follow-up of subjects to at least one year	1 year
Secondary	Time to Progression	Time to progression (TTP) determined by radiological assessment using mRECIST criteria	2 years
Secondary	Time to Extrahepatic Spread	Time to Extrahepatic Spread for each subject	2 years
Secondary	Proportion Progression Free	Proportion Progression-Free (PPF) at one year	1 year
Secondary	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.	2 years