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Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma

NCT01405573 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-03-28

No results posted yet for this study

Summary

The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best supportive care with best supportive care alone in terms of survival in patients with hepatocellular carcinoma (HCC) with impaired liver function (Child B).

Conditions

  • Advanced Adult Hepatocellular Carcinoma

Interventions

OTHER

Best Supportive Care

Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.

DRUG

sorafenib

400 mg twice a day

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Bruno Daniele, M.D. · Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology

  • Francesco Perrone, M.D., Ph.D · National Cancer Institute Naples, Italy; Director Clinical Trials Unit

  • Ciro Gallo, M.D., Ph.D · Second University of Naples, Italy; Chair of Medical Statistics

  • Antonio Gasbarrini, M.D. · Università Cattolica del S. Cuore, Policlinico Gemelli, Roma

  • Giacomo Carteni', M.D. · Ospedale Antonio Cardarelli, Napoli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT01405573 on ClinicalTrials.gov