Liver Neoplasms
Conditions
Keywords
hepatocellular, carcinoma, liver, cancer
Brief summary
The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma \[HCC\]).
Interventions
DRUGSeocalcitol
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Primary purpose
OTHER
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, defined as the time from start of treatment to death | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve partial/complete response | — |
| Time to progression measured from start of treatment | — |
| HCC-specific survival from start of treatment | — |
| Duration of complete response in patients showing a complete response, measured from the first date when absence of disease was recorded until the first date of disease progression was recorded | — |
| Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed | — |
| Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed | — |
| Time to response from start of treatment (complete or partial response) | — |
| Change in tumour marker | — |
| Number of days of hospitalisation (in-patient care) | — |
| Quality of life | — |
| Adverse events | — |
| Change in laboratory values | — |
| Dose of seocalcitol (seocalcitol treated patients) | — |
| Change(s) in tumour size | — |
Countries
Canada, France, Italy, Spain, United Kingdom
Outcome results
None listed