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Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis

NCT01357486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-05-01

No results posted yet for this study

Summary

The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in France and about 2 / 3 of patients, are not eligible for curative treatment at the time of diagnosis. The palliative management of patients with advanced and symptomatic disease is complex and requires treatment combining anti-tumor activity and safety in patients with impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the benefit of sorafenib in patient with altered liver function is uncertain. The aim of this trial is to study the interest of sorafenib in patients with HCC and impaired liver function compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination sorafenib/pravastatin or to best supportive care (usually used in these patients).

Conditions

Interventions

DRUG

sorafenib

patients receiving sorafenib 400 mg - twice a day

DRUG

Pravastatin

patients receiving pravastatin 40 mg - once a day

DRUG

Sorafenib + Pravastatin

patients receiving sorafenib 400 mg (twice a day) and pravastatin 40 mg (once a day)

OTHER

patients receiving best supportive care

palliative management

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • UNICANCER

    collaborator OTHER

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Jean-Frédéric BLANC, MD-PhD · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-14
Primary Completion
2017-04-12
Completion
2017-04-12

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01357486 on ClinicalTrials.gov