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 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.

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. 1. Age 18 or older2. Patient has signed informed consent3. Patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following:
      1. 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.
      2. 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.
      3. d. Patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.
  2. Patients not suitable for ablation due to lesion location may be enrolled
    1. e. Patient MUST meet at least ONE of the following criteria:
    2. i. Stage Child-Pugh B 7 ii. Recurrent HCC iii.Performance status ECOG 1
    3. f. Patient has a life expectancy of at least 6 months
    4. 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. 1. Current or previous treatment with chemo- or radiation therapy or sorafenib2. Previous treatment with any form of transarterial embolization for HCC3. Patients with current or history of any other cancer except non-melanomatous skin cancer4. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive5. Performance status ECOG \> 26. Child-Pugh scores \>77. Active gastrointestinal bleeding8. Evidence of uncorrectable bleeding diathesis9. Extra-hepatic spread of the HCC10. Total Bilirubin \> 3 mg/dL11. \>50% tumor involvement of the liver12. Infiltrative or diffuse HCC13. Encephalopathy not adequately controlled medically14. Presence of ascites not controlled medically15. Presence of medically relevant localized or systemic infection, other than hepatitis B, C, D, E or G16. Any contraindication for MRI (eg. metallic implants)17. Allergy to contrast media that cannot be managed with prophylaxis18. Allergy to iodized oil19. Any contraindication to arteriography20. Any contraindication for doxorubicin administration, including the following:
      1. i. White Blood Cell count (WBC) \<3000 cells/mm₃
      2. ii. Absolute Neutrophil \<1500 cells/mm₃
      3. iii. Cardiac ejection fraction \<50%
      4. iv. Other condition deemed exclusionary by physician
      5. u. Any contraindication for hepatic embolization, including the following:
      6. i. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization
      7. ii. Hepatofugal blood flow
      8. iii. Serum creatinine \> 2mg/dL
      9. iv. Uncorrectable impaired clotting
    2. 1. Platelet \<50,000/mm₃2. International Normalized Ratio (INR) \> 1.43. Activated Prothrombin Time (aPTT) less than 21 or greater than 40
      1. v. AST \> 5X upper limit of normal for lab
      2. vi. ALT \> 5X upper limit of normal for lab
View All Criteria
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Investigator(s)

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD
Interventional radiologist
Professor of Radiology (Interventional 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
Rajesh Shah
Rajesh Shah
Interventional radiologist
Clinical Associate Professor, Radiology
Lawrence "Rusty" Hofmann, MD
Lawrence "Rusty" Hofmann, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
David Hovsepian, MD
David Hovsepian, MD
Interventional radiologist, Radiologist
Clinical Professor, Radiology - Pediatric Radiology
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)

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov