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Keep this study
Lead
Boston Scientific Corporation
With
Biocompatibles UK Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Eastern Cooperative Oncology Group (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/L or \> 50% prothrombin activity
Hemoglobin ≥ 8.5 g/dL
Bilirubin ≤ 2.5 mg/dL
Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)\< 5 X upper limit of normal
Amylase or lipase ≤ 2X upper limit of normal
Serum creatinine ≤ 1.5 X upper limit of normal
International normalized ratio (INR) \< 2.0
You may not be if
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.
History of organ allograft
Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled severe hypertension or history of cardiac arrhythmias, congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc \>450ms, evidence of torsades de pointe, 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 Cytochrome P450 (CYP) 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
Taking any UDP-glucuronosyltransferase (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 chest, liver or abdomen
Prior yttrium-90 microsphere treatment to the liver
Prior treatment with transarterial chemoembolization (TACE) or bland embolization must have occurred \>2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol. For patients with tumor progression in the treatment field and /or lobe previously treated with TACE, vessels feeding the tumor(s) must be assessed for adequate blood flow using angiography (cone beam computerized tomography (CBCT) strongly recommended), and TACE or bland embolization must have been applied \>6 months prior to randomization.
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 given for more than 4 weeks during the 2 previous months prior to randomization, no prior sorafenib related toxicity
Evidence of pulmonary insufficiency or inadequately treated moderate grade or severe/very severe grade 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. Patients infected with HIV can be considered, however, they must be well managed and well controlled with undetectable viral load
Participation in concurrent clinical trials evaluating treatment intervention(s)
Clareo Health | Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer
