Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

- Age > 18 years;

- ECOG PS 0-2;

- Histologically or cytologically documented unresectable HCC;

- Measurable disease by RECIST criteria;

- Previous local therapy completed > 6 weeks;

- Any acute toxicity (CTC-AE) < grade 1;

- Child-Pugh A-B

- 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 ≥ 60,000/µl;

- Hb ≥ 8.5 g/dl;

- Creatinine ≤ 1.5 x ULN; AND

- Amylase and lipase < 1.5 x ULN

Exclusion Criteria:

- Metastatic tumors;

- Prior or concomitant systemic anti-cancer treatment for HCC, including:

- Systemic chemotherapy (TACE is allowed)

- Immunotherapy

- Farnesyltransferase 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;

- Patients taking narrow therapeutic index medications will be monitored closely. These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine, and digoxin.