Ensayos clínicos

Study closed to enrollment

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
• Must not have a history of organ allograft
• 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
  • Limited sorafenib exposure allowed
• 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