Liver NeoplasmsPhase 3NCT00051545
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
A Phase 3 study testing Seocalcitol in people with Liver Neoplasms, run by LEO Pharma at 5 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Seocalcitol
- How many people
- 608 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Nov 1999to Jun 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Canada1 site
E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)
Toronto, Ontario, M5G2C4
France1 site
E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)
Metz, F-57038 Metz Cedex
Italy1 site
E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)
Milan, I-20 122
Spain1 site
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
Barcelona, E-08036
United Kingdom1 site
E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
Edinburgh, EH3 9YW
About this study
Official title: 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).
- Conditions
- Liver Neoplasms
- Being tested
- Seocalcitol
- Keywords
- liver, cancer, hepatocellular, carcinoma
- Medical subject headings
- Liver Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeocalcitolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Secondary outcomes (11)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2003 (estimated)
- Study startNov 1999
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 608 participants
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hanne Hvidberg, MScPharm PhD, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051545
- Sponsor's protocol ID
- EBC 9802 INT
- Status last verified
- Apr 2005
- First submitted
- 13 Jan 2003
- Last updated
- 25 Feb 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00051545
- Acronym / sponsor ID
- EBC 9802 INT
- Conditions
- Liver Neoplasms
- Keywords
- liver, cancer, hepatocellular, carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 608 participants
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Study completion
- Jun 2004
- First posted
- 14 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seocalcitol | Drug | – |
Primary outcome
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
11 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Hvidberg, MScPharm PhD study director
LEO Pharma
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seocalcitol in people with Liver Neoplasms, run by LEO Pharma at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, France, Italy, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.