Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients With Hepatocellular Carcinoma Not Amenable to Curative Treatment

The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]).

Inclusion Criteria:

• Hospital in- or out-patients
• Either sex
• Aged 18-75 years
• With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.
• Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.

Exclusion Criteria:

• Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1
• Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years
• A history of renal stone(s)
• A life expectancy of < 3 months
• World Health Organization (WHO) performance status 3 or 4
• Okuda stage III.
• Patients with hypercalcemia, or other clinically important laboratory abnormalities
• Patients with previous/current calcium metabolic disease, taking calcium-lowering therapy, or medication known to affect systemic calcium metabolism are also excluded.
• All patients must give their signed informed consent to join the study.