Liver Neoplasms
Conditions
Keywords
liver, cancer, hepatocellular, carcinoma
Brief summary
To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).
Interventions
DRUGSeocalcitol
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 * 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 inclusion. * All patients must give their signed informed consent to join the study.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to distant recurrence of HCC | — |
| Time to second primary HCC | — |
| Time to development of metastases | — |
| Tumour measurements | — |
| Tumour marker (alpha-fetoprotein AFP) | — |
| Survival | — |
| Length of hospital stay | — |
| Adverse events | — |
| Laboratory safety examinations | — |
| Dose of Seocalcitol | — |
| Quality of life | — |
Countries
Canada, France, Italy, Spain, United Kingdom
Outcome results
None listed