Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein

Exclusion Criteria

• •Confirmed extra hepatic metastases. Participants with indeterminate hepatic hilar lymph nodes up to 2.5 centimeters (cm) in greatest dimension, or with indeterminate lung nodules (single lesion between 1-1.5 cm, or multiple smaller lesions with a total diameter of ≤2 cm) may be included if metastatic disease is deemed unlikely
• •Known contraindication to standard-of-care sorafenib including allergic reaction, pill swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, and renal failure including dialysis
• •Evidence of hepatic vein invasion or caval thrombosis
• •Evidence of chronic obstructive pulmonary disease
• •Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation)
• •Previous treatment with sorafenib for more than 4 weeks during the previous 2 months; prior sorafenib-related toxicity
• •Initiation of anti-tumor therapy including chemotherapy or investigational drug treatment within 30 days before beginning study
• •Prior transarterial chemoembolization (TACE) \<6 months prior to screening phase in case of participants progressing from an intermediate to an advanced stage due to occurrence of PVT
• •On a transplant list
• •History of organ allograft
• •Contraindications to angiography or selective visceral catheterization
• •History of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically
• •Prior external beam radiation therapy to the liver
• •Evidence of continuing adverse effect of prior therapy
• •Active gastrointestinal (GI) bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents
• •Evidence of any disease or condition that would place the participant at undue risk and preclude safe use of TheraSphere treatment
• •Females of child-bearing potential must have a negative serum test
• •No participation in concurrent clinical trials