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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


Inclusion Criteria:



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:

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) outside normal limits

v. AST > 5X upper limit of normal for lab

vi. ALT > 5X upper limit of normal for lab

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Median overall survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michael Soulen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

HCC-P3-11-01

NCT ID:

NCT01387932

Start Date:

April 2011

Completion Date:

December 2020

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • TACE
  • HepaSphere Microspheres
  • QuadraSphere Microspheres
  • Doxorubicin
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Stanford UniversityStanford, California  94305
Mount Sinai Medical CenterNew York, New York  10029
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Northwestern UniversityChicago, Illinois  60611
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Albany Medical CenterAlbany, New York  12208
UCLALos Angeles, California  90095
Tampa General HospitalTampa, Florida  33606
Ut Southwestern Medical CenterDallas, Texas  75390
Tuscon Medical CenterTuscon, Arizona  85711
Albert Einstein HealthcarePhiladelphia, Pennsylvania  19141
MUSC Medical Center (Medical University of South Carolina)Charleston, South Carolina  29425
St. Lukes HospitalHouston, Texas  77030
UT Health and Science CenterSan Antonio, Texas  78229