Sorafenib Plus Tegafur/Uracil (UFUR®) for Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

* Age \> 18 years;
* ECOG PS 0-2;
* Histologically or cytologically documented unresectable and/or metastatic HCC;
* Measurable disease by RECIST criteria;
* Previous local therapy completed \> 6 weeks;
* Any acute toxicity (CTC-AE) \< grade 1;
* Child-Pugh A;
* Liver transaminases ≤ 5 x ULN;
* Albumin ≥ 2.8 g/dl;
* Serum total bilirubin ≤ 3 mg/dl;
* INR ≤ 2.3 or PT ≤ 6 seconds above control;
* WBC ≥ 3,000/µl;
* ANC ≥ 1,500/µl;
* Platelets ≥ 100,000/µl;
* Hb ≥ 8.5 g/dl;
* Creatinine ≤ 1.5 x ULN; AND
* Amylase and lipase \< 1.5 x ULN

Exclusion Criteria:

* Metastatic brain/leptomeningeal tumors;
* Prior or concomitant systemic anti-cancer treatment for HCC, including:

  * Systemic chemotherapy (TACE is allowed)
  * Immunotherapy
  * Hormonal therapy (hormonal therapy used for supportive used is allowed)
  * Raf-kinase inhibitors
  * MEK inhibitors
  * Farnesyl transferase inhibitors
  * VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
  * Investigational anti-cancer agents
* Severe and/or uncontrolled medical conditions:

  * Uncontrolled high blood pressure
  * History of poor compliance with anti-hypertensive agents
  * Active or uncontrolled infection
  * Unstable angina
  * CHF
  * MI or CVA \< 6 months
  * GI bleeding \< 30 days
  * Unable to take oral medications
* Severe renal impairment which requires dialysis; proteinuria \> grade 2;
* BMT or stem cell rescue \< 4 months; organ transplant;
* HIV infection;
* Major surgical procedure, open biopsy, or significant traumatic injury \< 4 weeks or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 2 weeks;
* Receive central venous line placement within 7 days;
* Patients who anticipate receiving major surgery during the course of the study;
* Use rifampin, St. John's Wort \[Hypericum perforatum\];
* Patients taking narrow therapeutic index medications will be monitored closely. These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine, and digoxin; OR
* Patients for whom tegafur is contra-indicated