A Randomized, Controlled Phase III Trial of Sorafenib With or Without Conventional Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma (STAH Study)
To be eligible to participate in the study, patients must meet the following criteria:
1. Signed written informed consent
2. Clinical or histological diagnosis of HCC based on the guidelines of the Korean Liver
Cancer Study Group and the National Cancer Center Korea
3. At least one typical enhanced index lesion in the liver that is bi-dimensionally
measurable by multiphasic spiral CT scan or dynamic contrast-enhanced MRI, and size
of largest tumor is 15 cm or less at enrollment.
4. Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) and
chest imaging (CT) performed within 4 weeks prior to the treatment initiation:
5. Age of at least 20 years.
6. ECOG Performance Status of 0, 1 or 2.
7. Child-Pugh class A or B (Child-Pugh score ≤ 7).
8. Life expectancy of at least 16 weeks.
9. Adequate bone marrow, liver, and renal function as assessed by the following
laboratory requirements (no transfusion, no restoration), conducted within 14 days
prior to screening:
10. Female patients at least 1 year postmenopausal, surgically sterile or those of
childbearing potential must have a negative urine pregnancy test within 14 days prior
to the first treatment, and have to use at least one medically acceptable and
effective contraceptive method for the last 2 months prior to Screening Visit:
methods of effective contraception result in a low failure rate (i.e. less than 1%
per year) when used consistently and correctly such as a barrier method (implant,
injectable contraceptives, oral contraceptives, intrauterine contraceptive device),
hormonal IUD, sexual abstinence or vasectomized partner.