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
- 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
- Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before
- 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.