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


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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 ≥ 85 mg/mL - Bilirubin ≤ 2 mg/dL - ALT and AST ≤ 5 X upper limit of normal - Amylase and lipase 1,5 X 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) - Eligible for transarterial chemoembolization (TACE) - 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, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis - Must not be taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone - Must not be taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan) - Must not be taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide) - Must not be taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan) - Must not be taking P-Gp substrates (e.g. Digoxin) - Prior liver resection < 6 months prior to randomization - 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 < 6 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 - History of pulmonary compromise, such as 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

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