A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma

Stopped early · Phase 3

Conditions studied: Hepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02460991

Run by

Boston Scientific Corporation

People needed

2

Starts

2015-11-01

Expected to finish

2017-06-05

Last updated by the study team

2021-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written Informed Consent
• ≥18 years of age
• Diagnosis of HCC
• Locally advanced HCC
• Preserved liver function
• Eastern Cooperative Oncology Group 0 or 1

You may not qualify if…

• 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.

Where it is running

• University of Alabama Hospital — Birmingham, Alabama, United States
• University of Southern California — Los Angeles, California, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Oregon Health & Science University — Portland, Oregon, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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