This study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

• Conditions: Hepatocellular Carcinoma; MedDRA version: 18.1Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002740-13-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-30
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 908

Inclusion Criteria

-Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
-Locoregional therapy for HCC must be completed at least 4 weeks prior to the baseline scan.
-Child-Pugh Class A
-Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 545
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 363

Exclusion Criteria

-Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
-Prior liver transplant
-Active, known, or suspected autoimmune disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified