A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma



Status:Terminated
Conditions:Liver Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:November 2015
End Date:June 5, 2017

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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.

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.

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.
We found this trial at
6
sites
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Anthony El-Khoueiry
University of Southern California The University of Southern California is one of the world’s leading...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Gina Vaccaro
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Howard Richard
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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Birmingham, Alabama 35294
Principal Investigator: Ahmed Kamel
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Birmingham, AL
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Houston, Texas 77030
Principal Investigator: Bruno Odisio
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Houston, TX
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Robert Martin
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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