Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

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

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).

Study Overview

• Status: Terminated
• Conditions: Liver Neoplasms
• Intervention / Treatment: Drug: Seocalcitol

• Study Type: Interventional
• Enrollment: 608
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2C4
      • E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)
• France
  • Metz, France, F-57038 Metz Cedex
    • E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)
• Italy
  • Milano, Italy, I-20 122
    • E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)
• Spain
  • Barcelona, Spain, E-08036
    • E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
• United Kingdom
  • Edinburgh, United Kingdom, EH3 9YW
    • E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Hanne Hvidberg, MScPharm PhD, LEO Pharma

Publications and helpful links

Helpful Links

• Clinical Trials at LEO Pharma

Study record dates

Study Major Dates

• Study Start: November 1, 1999
• Study Completion: June 1, 2004

Study Registration Dates

• First Submitted: January 13, 2003
• First Submitted That Met QC Criteria: January 13, 2003
• First Posted (Estimated): January 14, 2003

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: April 1, 2005

More Information

Terms related to this study

• Keywords: carcinoma; cancer; liver; hepatocellular
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Seocalcitol
• Other Study ID Numbers: EBC 9802 INT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO