Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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).

Official Title
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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

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 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.

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
Intervention Model: Parallel Assignment
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 |
| --- | --- | --- |
| Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Time to distant recurrence of HCC |  |  | 
| Time to second primary HCC |  |  | 
| Time to development of metastases |  |  | 
| Tumour measurements |  |  | 
| Tumour marker (alpha-fetoprotein AFP) |  |  | 
| Quality of life |  |  | 
| Length of hospital stay |  |  | 
| Adverse events |  |  | 
| Laboratory safety examinations |  |  | 
| Dose of Seocalcitol |  |  | 

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