Purpose / Objectives

Primary Outcome

Overall Survival(OS)

Secondary Outcomes

Time To Progression (TTP)
Progression Free Survival (PFS)
Objective Tumor Response Rate (ORR)
Disease Control Rate (DCR=CR+PR+SD)

Diagnosis

• Liver cell carcinoma
• Carcinoma, Hepatocellular

Patient attributes

Inclusion criteria

 Signed informed consent (IC) obtained before any study specific procedure.

Patients must be able to understand and willing to sign the written informed

consent.

 Male or female patients  18 years of age.

 Histological or cytological confirmation of HCC or non-invasive diagnosis of

HCC as per American Association for the Study of Liver Diseases (AASLD)

criteria (See Section 14.7) in patients with a confirmed diagnosis of cirrhosis.

 Barcelona Clinic Liver Cancer (BCLC) stage Category B or C that cannot

benefit from treatments of established efficacy with higher priority such as

resection, local ablation, chemoembolization or systemic sorafenib. Reference

to liver transplantation was deleted in Amendment 2 (see Section 13.2.2.3).

 Failure to prior treatment with sorafenib (defined as documented radiological

progression according to the radiology charter). Randomization needs to be

performed within 10 weeks after the last treatment with sorafenib. The bold text

replaced the original text in Amendment 2 (see Section 13.2.2.3).

 Tolerability of prior treatment with sorafenib defined as not less than 20 days at

a minimum daily dose of 400 mg QD within the last 28 days prior to

withdrawal.

 Liver function status Child-Pugh Class A. Child Pugh status should be

calculated based on clinical findings and laboratory results during the screening

period.

 Local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery,

radiation therapy, hepatic arterial embolization, chemoembolization,

radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must

Exclusion criteria

 -Prior liver transplantation or candidates for liver transplantation
- Prior treatment with regorafenib. Patients permanently withdrawn from study
participation will not be allowed to re-enter the study.
-Prior systemic treatment for HCC, except sorafenib.
-Permanent discontinuation of prior sorafenib therapy due to sorafenib related toxicity.

Trial design

• Phase III
• Randomized
• Two-arm
• Double-blind

Documents (password protected)

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Responsibilities in overall trial

Sponsor

Bayer HealthCare AG

National Coordinating Investigator

Prof. Dr. med. Markus-Alexander Woerns

Study Sites