Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

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

Official Title
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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

Conditions
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Liver Neoplasms

Intervention / Treatment
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* Drug: Seocalcitol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seocalcitol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, defined as the time from start of treatment to death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC-specific survival from start of treatment |  |  | 
| Time to response from start of treatment (complete or partial response) |  |  | 
| Proportion of patients who achieve partial/complete response |  |  | 
| Time to progression measured 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 |  |  | 
| Change(s) in tumour size |  |  | 
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular, carcinoma, liver, cancer