A Randomized Controlled Trial of Transcatheter Arterial Chemoembolization with Drug-Eluting Beads (DEB-TACE) Versus Sorafenib in the Treatment of
Bruno C. Odisio
The goal of this clinical research study is to learn if Oncozene™ Microspheres combined with doxorubicin (ONCO-DOX) are safe and effective as treatment for patients with HCC. In this study, ONCO-DOX will be compared with standard treatment (sorafenib).
Disease Group: Liver
Treatment Agent: Doxorubicin,ONCOZENE Microspheres,Sorafenib
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Boston Scientific
The main objective of this study is to evaluate the safety and efficacy of drug-eluting beads transarterial chemoembolization (DEB-TACE) with ONCOZENE™ Microspheres loaded with Doxorubicin (ONCO-DOX) in comparison with orally administered Sorafenib for the treatment of patients with unresectable, locally-advanced hepatocellular carcinoma (HCC). Primary Effectiveness Endpoint The primary effectiveness endpoint for this clinical trial is the overall survival in HCC patients with minimum follow-up of patients to at least one year. The DEB-TACE test arm will be compared to sorafenib in the group of HCC patients enrolled in this trial. The primary hypothesis is a superiority hypothesis that the overall survival in the ONCOZENE™ Microspheres embolization and drug delivery arm is higher than the overall survival for sorafenib at one year after initial dose. Secondary Endpoints The secondary endpoints of this study are: Time to Progression (TTP) determined by radiological assessment using mRECIST criteria Time to Extrahepatic Spread Proportion Progression-Free (PPF) at one year. 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. Additional Endpoints Two additional endpoints are studied in this trial. 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. The data from the tumor response will be presented descriptively by treatment group without a test of hypothesis. The second additional endpoint is the FACT-Hep quality of life instrument validated in patients with Hepatic cancer.
IRB Review and Approval Date: 11/09/2015
Recruitment Status: Not Accepting
Projected Accrual: 244
1) Patient is able to provide informed consent and must sign the
Institutional Review Board/Ethics Committee (IRB/EC) approved Informed
2) Male or female of age = 18 years.
3) Confirmed diagnosis of HCC by imaging according to AASLD or EASL criteria or biopsy proven.
4) Locally-advanced HCC defined as tumor showing at least two of the following features: a. Multinodularity (>4 lesions) b. Large size (>5 cm) c. Segmental branch portal vein invasion.
5) Preserved liver function (Child-Pugh A or B7 without clinically relevant ascites “treatable ascites”).
6) ECOG Performance Status 0 or 1.
1) Presence of extra-hepatic spread of disease.
2) Macrovascular invasion of lobar portal vein branches or main portal vein at entry into the study.
3) Candidate for surgical resection, transplantation, or local ablation.
4) Prior intra-arterial therapy or systemic therapy for treatment of HCC.
5) Any contraindication for TACE.
6) Platelet count <50,000/mm3 or INR >1.5.
7) Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.
8) Unstable coronary artery disease or recent MI (i.e. within 1 year).
9) Known ejection fraction < 50%.
10) Current infections requiring antibiotic therapy.
11) On anticoagulation or suffering from a known bleeding disorder.
12) Renal insufficiency (serum creatinine > 2 mg/dL).
13) AST and/or ALT >5 times upper limit of normal.
14) Presence of advanced liver disease including active gastrointestinal bleeding, hospitalization for encephalopathy within 1 year, and clinically relevant ascites.
15) Any contraindication for doxorubicin administration: a. Serum Bilirubin>2mg/dL b. WBC < 3,000 cell/mm3 c. Neutrophil < 1,500 cell/mm3
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 (signing informed consent).
19) Pregnant or breast-feeding patients. Women of childbearing potential must have negative serum pregnancy test performed within 7 days prior to start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the treatment period.
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Bruno C. Odisio
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