Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma
- Hospital in- or out patients
- Either sex
- 18 to 75 years of age
- With hepatocellular carcinoma treated successfully with surgical resection or
percutaneous ablative treatment within 4 and 8 weeks, respectively, prior to
- All patients must give their signed informed consent to join the study.
- Patients previously treated with any anti-cancer therapy for HCC except for surgical
resection and percutaneous ablative therapy
- Patients treated with chemotherapy or other anti-cancer therapy (except surgical
resection or percutaneous ablative treatment) in the previous 4 weeks
- Patients with another primary tumor except basocellular carcinoma of the skin or in
situ carcinoma of the cervix within the last 2 years
- With a history of renal stone(s)
- With a life expectancy < 3 months
- WHO performance status 3 or 4.
- Patients with hypercalcemia (ionised serum calcium > 1.35 mmol/l or albumin corrected
serum calcium > 2.68 mmol/l), previous/current calcium metabolic disease, taking
calcium-lowering therapy or medication known to affect systemic calcium metabolism,
or with marked laboratory abnormalities.
- Patients with recurrent hepatocellular carcinoma, with known extrahepatic metastases,
Okuda stage III disease and patients with a Child-Pugh score of C are also excluded.