Clinical trial · Interventional
Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
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
NCT00051532CI-TRIAL-00086453terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma \[HCC\]).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Seocalcitol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival, defined as the time from start of treatment to death
Secondary outcomes (14)
- measure
- HCC-specific survival from start of treatment
- measure
- Time to response from start of treatment (complete or partial response)
- measure
- Proportion of patients who achieve partial/complete response
- measure
- Time to progression measured from start of treatment
- measure
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.