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

Trial ID or NCT#

NCT01387932

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to evaluate overall survival in patients treated with HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with particle PVA.

Official Title

Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Patients must meet all of the following inclusion criteria in order to be entered into the study: 1. Age 18 or older 2. Patient has signed informed consent 3. 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
Exclusion Criteria:
  1. If patients meet any of the following criteria they may not be entered into the study: 1. Current or previous treatment with chemo- or radiation therapy or sorafenib 2. Previous treatment with any form of transarterial embolization for HCC 3. Patients with current or history of any other cancer except non-melanomatous skin cancer 4. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive 5. Performance status ECOG > 2 6. Child-Pugh scores >7 7. Active gastrointestinal bleeding 8. Evidence of uncorrectable bleeding diathesis 9. Extra-hepatic spread of the HCC 10. Total Bilirubin > 3 mg/dL 11. >50% tumor involvement of the liver 12. Infiltrative or diffuse HCC 13. Encephalopathy not adequately controlled medically 14. Presence of ascites not controlled medically 15. Presence of medically relevant localized or systemic infection, other than hepatitis B, C, D, E or G 16. Any contraindication for MRI (eg. metallic implants) 17. Allergy to contrast media that cannot be managed with prophylaxis 18. Allergy to iodized oil 19. Any contraindication to arteriography 20. 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 u. Any contraindication for hepatic embolization, including the following: i. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization ii. Hepatofugal blood flow iii. Serum creatinine > 2mg/dL iv. Uncorrectable impaired clotting 1. Platelet <50,000/mm₃ 2. International Normalized Ratio (INR) > 1.4 3. Activated Prothrombin Time (aPTT) less than 21 or greater than 40 v. AST > 5X upper limit of normal for lab vi. ALT > 5X upper limit of normal for lab

Investigator(s)

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Rajesh Shah
Rajesh Shah
Interventional radiologist
Clinical Associate Professor, Radiology
Gloria Hwang, MD
Gloria Hwang, MD
Interventional radiologist
Clinical Professor, Radiology
David S. Wang, MD
David S. Wang, MD
Interventional radiologist, Radiologist, Minimally invasive surgeon, Diagnostic radiologist
Clinical Associate Professor, Radiology
David Hovsepian, MD
David Hovsepian, MD
Interventional radiologist, Radiologist
Clinical Professor, Radiology
John D. Louie, MD
John D. Louie, MD
Interventional radiologist
Clinical Professor, Radiology
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FACR, FCIRSE
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Nishita Kothary, MD
Nishita Kothary, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Lawrence "Rusty" Hofmann, MD
Lawrence "Rusty" Hofmann, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)

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CONTACT

CCTO
(650) 498-7061