Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:March 2012
End Date:September 2019

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A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable
hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All
patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.


Inclusion Criteria:

- Signed informed consent prior to any study-related evaluation

- Male or female patients over 18 years of age

- Unresectable HCC confirmed by histology or by non-invasive AASLD criteria

- Measurable disease defined as at least one uni-dimensional measurable lesion by CT or
MRI according to RECIST 1.1

- Child Pugh score ≤ 7 points

- ECOG Performance Status score of ≤ 1

- Life expectancy of 12 weeks or more

- Eligible to receive standard-of-care sorafenib

- Platelet count of > 50 x 10⁹ or > 50% prothrombin activity

- Hemoglobin ≥ 8.5 g/dL

- Bilirubin ≤ 2.5 mg/dL

- ALT and AST< 5 X upper limit of normal

- Amylase and lipase ≤ 2X upper limit of normal

- Serum creatinine ≤ 1.5 X upper limit of normal

- INR < 2.0

Exclusion Criteria:

- Main portal vein thrombosis

- Eligible for curative treatment (ablation or transplantation)

- History of previous or concurrent cancer other than HCC unless treated curatively 5 or
more years prior to entry

- Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or
portal lymph nodes ≤ 2.0 cm each

- Risk of hepatic or renal failure

- Tumor replacement > 70% of total liver volume based on visual estimation by
investigator OR tumor replacement >50% of total liver volume in the presence of
albumin <3 mg/dL

- History of severe allergy or intolerance to contrast agents, narcotics sedatives or
atropine that cannot be managed medically

- Contraindications to angiography and selective visceral catheterization

- Known contraindications to sorafenib including allergic reaction, pill-swallowing
difficulty, evidence of severe or systemic diseases, uncontrolled hypertension or
history of cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker),
congestive heart failure . New York Heart Association class 2, myocardial infarct
within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of
the investigator makes it undesirable for the patient to participate in the trial,
significant GI bleed within 30 days, metastatic brain disease, renal failure requiring
dialysis

- Taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine,
phenobarbital, dexamethasone

- Taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)

- Taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz,
ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)

- Taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)

- Taking P-Gp substrates (e.g. Digoxin)

- Prior liver resection must have taken >2 months prior to randomization

- Treatment with other locoregional therapies (other than study treatment) has not been
planned for the duration of the clinical study period

- Prior external beam radiation treatment to the liver or abdomen

- Prior yttrium-90 microsphere treatment to the liver

- Prior treatment with transarterial chemoembolization (TACE) or bland embolization >2
months prior to randomization and must have been applied to a treatment field and/or
lobe not targeted for treatment under this protocol

- Anti-cancer therapy or any treatment with an investigational agent within 30 days
prior to randomization

- Adverse effects due to prior therapy unresolved at randomization

- Prior systemic treatment for the treatment of HCC, including sorafenib

- Evidence of pulmonary insufficiency or clinically evident chronic obstructive
pulmonary disease

- Intervention for, or compromise of, the Ampulla of Vater

- Clinically evident ascites (trace ascites on imaging is acceptable)

- Pregnancy or breast feeding

- Women of child-bearing potential must have a negative serum pregnancy test within 14
days prior to randomization

- Disease or condition that would preclude safe use of TheraSphere, including concurrent
dialysis treatment, or unresolved serious infections including patients who are known
HIV positive

- Participation in concurrent clinical trials evaluating treatment intervention(s)
We found this trial at
20
sites
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Laura Kulik, MD
Phone: 312-695-1518
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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164 Moorselbaan
Aalst, 9300
Principal Investigator: Koen dR Hendrickx, MD
Phone: +32 53 72 45 02
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Aalst,
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: James Stone, MD
Phone: 434-982-5037
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Sheila Eswaran, MD
Phone: 312-942-1372
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Ron Gaba, MD
Phone: 312-355-5112
University of Illinois at Chicago A major research university in the heart of one of...
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Shannon Kauffman, MD
Phone: 937-208-2872
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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3990 John R Street
Detroit, Michigan 48201
Principal Investigator: Philip Philip, MD
Phone: 313-576-9385
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Detroit, MI
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Evanston, Illinois 60201
Principal Investigator: Claus Fimmel, MD
Phone: 847-570-3708
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Grand Rapids, Michigan 49503
Principal Investigator: Matthew Tiede, MD
Phone: 616-685-5156
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indianapolis, IN
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Robert Martin, MD, PhD
Phone: 502-629-3383
University of Louisville The University of Louisville is a state supported research university located in...
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New York, New York 10065
Principal Investigator: Adam Talenfeld, MD
Phone: 212-746-9748
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Norfolk, Virginia 23507
Principal Investigator: Harlan Vingan, MD
Phone: 757-388-5224
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Colette Shaw, MD
Phone: 215-955-4129
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: David Gellar, MD
Phone: 412-864-3292
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Lewis Roberts, MD
Phone: 507-266-4626
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Salt Lake City, Utah 84124
Principal Investigator: James Carlisle, MD
Phone: 801-268-7102
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Seattle, Washington 98109
Principal Investigator: Guy Johnson, MD
Phone: 206-288-6439
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Tampa, Florida 33612
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