Clinical trial NCT01887717 (phase 3, status: terminated)
Conditions: hepatocellular carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: sorafenib
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    poor accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Participants over 18 years of age, regardless of race or gender

          -  Advanced unresectable hepatocellular carcinoma with branch portal vein thrombosis
             (confirmed by non-invasive criteria European Association for the Study of the Liver
             [EASL]/American Association for the Study of Liver Diseases [AASLD], mandatory by
             histology in non-cirrhotic participants); can be naive or recurrent HCC after curative
             treatment ( >6 months before randomization)

          -  Unilobar disease

          -  Child Pugh A

          -  Tumor volume ≤70% of liver volume (determined by visual estimation)

          -  At least one uni-dimensional HCC target lesion assessable by computed tomography (CT)
             or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid
             Tumor (RECIST) version 1.1

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

          -  Platelets ≥ 50*10^3/microliter (µL)

          -  White blood cell (WBC) ≥1.5*10^3/microliter (µL)

          -  Aspartate transaminase (AST)/ alanine aminotransferase (ALT) ≤5 times upper limit of
             normal

          -  Creatinine ≤2.0 mg/deciliter (dL)

          -  Life expectancy >3 months

          -  Signed informed consent

        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