Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

• Status: Terminated
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Calcitriol; Seocalcitol

Criteria

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.