Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

Phase 3

Terminated

• Conditions: Liver Neoplasms

• Registration Number: NCT00051545
• Lead Sponsor: LEO Pharma

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).

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2003-01-13
• Study First Submitted QC: 2003-01-13
• Study First Posted: 2003-01-14
• Study Completion: 2004-06
• Status Verified: 2005-04
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 608

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France); 🇫🇷 Metz, France

E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting); 🇨🇦 Toronto, Ontario, Canada

E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain); 🇪🇸 Barcelona, Spain

E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy); 🇮🇹 Milano, Italy

E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK); 🇬🇧 Edinburgh, United Kingdom