Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

LEO Pharma

Status and phase

Terminated

Phase 3

Conditions

Liver Neoplasms

Treatments

Drug: Seocalcitol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00051545

EBC 9802 INT

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.