Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

LEO Pharma700 enrolled

Overview

The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma \[HCC\]).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

700

Conditions

Liver Neoplasms

Interventions

SeocalcitolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (5)

E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)

Toronto, Alberta, Canada

E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)

Metz, France

E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)

Milan, Italy

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

Outcomes

Primary Outcomes

Overall survival, defined as the time from start of treatment to death

Secondary Outcomes

HCC-specific survival from start of treatment

Time to response from start of treatment (complete or partial response)

Proportion of patients who achieve partial/complete response

Time to progression measured from start of treatment

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

Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed

Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed

Change(s) in tumour size

Change in tumour marker

Number of days of hospitalisation (in-patient care)

Quality of life

Adverse events

Change in laboratory values

Dose of seocalcitol (seocalcitol treated patients)

Data from ClinicalTrials.gov

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