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Seocalcitol in adjuvant hepatocellular carcinoma
NCT00051545Phase 3
Key facts
- Status
- Terminated
- Start
- Nov 1999
- Countries
- 5
- Sponsor
- LEO Pharma
- Modality
- Orthosteric Ligands
- Drugs
- seocalcitol
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 3, randomised, double-blind trial in hepatocellular carcinoma (HCC) comparing Seocalcitol with Placebo (2 arms). Primary endpoint: Time to relapse. Started Nov 1999; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Seocalcitol
Seocalcitol (EB 1089) enteric-coated capsules (5 ug)
Placebo
Placebo capsules
03
Who it enrols
Adult patients with hepatocellular carcinoma successfully treated with surgical resection or percutaneous ablative treatment within 4-8 weeks prior to inclusion. Excludes patients with prior anti-cancer therapy (other than curative), history of renal stones, hypercalcemia, Child-Pugh C, or Okuda stage III disease.
04
Endpoints
Primary
Time to relapse
Secondary
Overall Survival
Time to distant recurrence of HCC
Time to second primary HCC
Time to development of metastases
Tumour measurements
Alpha-fetoprotein
Quality of life
Length of hospital stay
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