Clinical trial NCT02288507 (phase 1, status: withdrawn)
Conditions: hepatocellular cancer
ICD codes: P59.20, P59.29
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: 
    closed due to no accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed HCC or clinical diagnosis by American
             Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is
             required. m)

          -  Barcelona Clinic Liver Cancer Stage B or C. Segmental and subsegmental portal vein
             thrombosis is allowed.

          -  Metastatic disease is allowed if investigator feels liver directed therapy could offer
             palliative benefit (i.e., minimal extrahepatic tumor burden)

          -  No evidence of cirrhosis or cirrhosis grade of Child-Pugh class A or B7. Eligibility

          -  Have at least one tumor lesion that can be accurately measured according to Response
             Evaluation Criteria in Solid Tumor (RECIST v1.1).

          -  Consultation with interventional radiologist and deemed an appropriate candidate for
             TARE.

          -  Prior local therapy, such as surgery, hepatic arterial embolization,
             chemoembolization, radiofrequency ablation, percutaneous ethanol injection or
             cryoablation is allowed if the index lesion(s) remains outside of the treatment field
             or has progressed since prior treatment. Local therapy must have been completed at
             least 4 weeks prior to the baseline scan.

          -  Prior yittrium-90 transarterial radioembolization (TARE) or sorafenib not allowed

          -  Patient must be informed of the investigational nature of this study, sign and give
             written informed consent in accordance with institutional and federal guidelines.

          -  Age ≥ 18 years.

          -  Eastern Cooperative Group (ECOG) performance status ≤ 1.

          -  Have adequate hematologic function as documented by an absolute neutrophil count (ANC)
             ≥ 1000/ul, platelet count ≥ 60,000/ul, and hemoglobin ≥ 8.5 mg/dl obtained within 28
             days prior to registration.

          -  Have adequate hepatic function, as determined by the following tests measured within
             28 days prior to registration: serum bilirubin ≤ 2 x upper limit of normal (ULN);
             serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate
             transaminase (SGPT) ≤ 5 x the institutional upper limit of normal (IULN).

          -  Have adequate renal function, as determined by the following tests measured within 28
             days prior to registration: serum creatinine ≤ 1.5 x ULN OR a measured creatinine
             clearance or calculated creatinine clearance ≥ 50 mL/min.

          -  Have a life expectancy of ≥12 weeks

          -  Must be able to swallow oral medications.

          -  Negative pregnancy test done ≤7 days prior to registration, for women of childbearing
             potential only.

        Exclusion Criteria:

          -  Known or suspected allergy or hypersensitivity to sorafenib.

          -  Any malabsorption condition.

          -  Must not have known brain metastases.

          -  No concurrent anticancer chemotherapy or local therapy.

          -  No concurrent herbal or unconventional therapy (e.g., St. John's Wort)

          -  Pregnant or nursing women

          -  No prior radiation therapy to the liver

          -  Inability to perform y90 TARE due to: (1) inability to catheterize the hepatic artery,
             (2) portal vein thrombosis/occlusion without the ability to perform selective
             infusion, (3) Tecnetium-99m macro-aggregated albumin hepatic artery perfusion
             scintigraphy shows unfavorable shunt fraction between the liver and the pulmonary
             parenchyma as determined by the interventional radiologist, or (4) other
             contraindication to TARE identified by interventional radiologist.

          -  Women/men of reproductive potential unwilling or unable to use an effective
             contraceptive method

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             Stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for 3 years.

          -  History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic
             conduction abnormality within 6 months.

          -  Concurrent severe or uncontrolled medical disease (i.e., active systemic infection,
             diabetes, coronary artery disease, congestive heart failure) that, in the opinion of
             the Investigator, would compromise the safety of the patient or compromise the ability
             of the patient to complete the study.