HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer

Stopped early · Phase 3

Conditions studied: Hepatocellular Carcinoma

In brief

The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.

Key facts

Study ID

NCT01387932

Run by

Merit Medical Systems, Inc.

People needed

235

Starts

2011-06-01

Expected to finish

2021-02-01

Last updated by the study team

2021-11-30

Who can join

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

You may qualify if…

• Patients must meet all of the following inclusion criteria in order to be entered into the study:
• Age 18 or older
• Patient has signed informed consent
• Patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following:
• i. Histological confirmation ii. Magnetic resonance imaging (MRI) result with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B.
• iii. Contrast enhanced computed tomography (CT) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B.
• d. Patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.
• Patients not suitable for ablation due to lesion location may be enrolled
• e. Patient MUST meet at least ONE of the following criteria:
• i. Stage Child-Pugh B 7 ii. Recurrent HCC iii.Performance status ECOG 1
• f. Patient has a life expectancy of at least 6 months
• g. Absence of occlusive thrombus to the main portal trunk

You may not qualify if…

• If patients meet any of the following criteria they may not be entered into the study:
• Current or previous treatment with chemo- or radiation therapy or sorafenib
• Previous treatment with any form of transarterial embolization for HCC
• Patients with current or history of any other cancer except non-melanomatous skin cancer
• Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
• Performance status ECOG > 2
• Child-Pugh scores >7
• Active gastrointestinal bleeding
• Evidence of uncorrectable bleeding diathesis
• Extra-hepatic spread of the HCC
• Total Bilirubin > 3 mg/dL
• >50% tumor involvement of the liver
• Infiltrative or diffuse HCC
• Encephalopathy not adequately controlled medically
• Presence of ascites not controlled medically
• Presence of medically relevant localized or systemic infection, other than hepatitis B, C, D, E or G
• Any contraindication for MRI (eg. metallic implants)
• Allergy to contrast media that cannot be managed with prophylaxis
• Allergy to iodized oil
• Any contraindication to arteriography
• Any contraindication for doxorubicin administration, including the following:
• i. White Blood Cell count (WBC) <3000 cells/mm₃
• ii. Absolute Neutrophil <1500 cells/mm₃
• iii. Cardiac ejection fraction <50%
• iv. Other condition deemed exclusionary by physician

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Tuscon Medical Center — Tucson, Arizona, United States
• Greater Arkansas Veterans Healthcare — Little Rock, Arkansas, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• Palo Alto Veterans Institute for Research — Palo Alto, California, United States
• Stanford University — Stanford, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Albany Medical Center — Albany, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Albert Einstein Healthcare — Philadelphia, Pennsylvania, United States
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States
• MUSC Medical Center (Medical University of South Carolina) — Charleston, South Carolina, United States
• UT Health and Science Center — San Antonio, Texas, United States
• University Hospitals K.U. Leuven (Dept of Hematology) — Leuven, Belgium
• Hospital Saint Andre — Bordeaux, France
• Hospital Paul Brousse — Villejuif, France
• Evgenidion University Hospital — Athens, Greece
• S. Croce e Carle Hospital — Cuneo, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.