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A Phase IV, Single-arm, Open-label Study of Sorafenib (Nexavar®) in Advanced Hepatocellular Carcinoma (HCC)

Phase 4
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

A Phase IV, Single-arm, Open-label Study of Sorafenib (Nexavar®) in Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

- Histologically or cytologically documented HCC (documentation of original biopsy for
diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by
American Association for the Study of Liver Disease (AASLD) criteria in cirrhotic
patients is required. For subjects without cirrhosis, histological or cytological
confirmation is mandatory.

- Unresectable advanced/or metastatic HCC not amenable to local treatment modalities

- Patients must have at least one tumor lesion that meets both of the following

1. The lesion can be accurately measured in at least one dimension according to
RECIST amendment (version 1.0)

2. The lesion has not been previously treated with local therapy (such as surgery,
radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency
ablation, percutaneous ethanol injection, or cryoablation).

- Patients who have received local therapy such as surgery, radiation therapy, hepatic
arterial embolization, chemoembolization, radiofrequency ablation, percutaneous
ethanol injection, or cryoablation are eligible. Previously treated lesions will not
be selected as target lesions. Local therapy must be completed at least 4 weeks
prior to the baseline scan.

- Cirrhotic status of Child-Pugh Class A. Child-Pugh status should be calculated based
on clinical findings and laboratory results during the screening period.

- Male or female patients >/= 18 years of age

- Patients who have a life expectancy of at least 12 weeks

- Patients who have an Eastern Cooperative Oncology Group (ECOG) performance score (PS)
of 0,1 or 2

- Resolution of all acute toxic effects of any prior local treatment to National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
- The following laboratory parameters:

1. Platelet count >/= 60 x 10^9/L

2. Hemoglobin >/= 8.5 g/dL

3. Total bilirubin
4. Alanine transaminase (ALT) and aspartate aminotransferase (AST) limit of normal

5. Serum creatinine
6. Prothrombin time-international normalized ratio (INR) above control.

- Patients who are being therapeutically anticoagulated with an agent such as warfarin
or heparin will be allowed to participate provided that no prior evidence of
underlying abnormality in these parameters exists. Close monitoring of at least
weekly evaluations will be performed until INR is stable based on a measurement at
pre dose, as defined by the local standard of care.

Exclusion Criteria:

- Previous or concurrent cancer that is distinct in primary site or histology from HCC,
except cervical carcinoma in situ, treated basal cell carcinoma, or superficial
bladder tumors (Ta, Tis &T1). Any cancer curatively treated > 3 years prior to entry
is permitted.

- Renal failure requiring hemo- or peritoneal dialysis.

- History of cardiac disease:

- Congestive heart failure > New York Heart Association (NYHA) class 2

- Active coronary artery disease (myocardial infarction more than 6 months prior to
study entry is permitted)

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than β-blockers or

- Uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg or diastolic
blood pressure > 90 mmHg despite optimal medical management.

- Active, clinically serious infections (> grade 2 NCI-CTCAE, version 4.0), except
HBV/HCV infections

- Known history of human immunodeficiency virus (HIV) infection or acquired
immunodeficiency syndrome (AIDS)-related illness or serious acute or chronic illness

- Known central nervous system tumors, including metastatic brain disease

- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry

- History of organ allograft

- Child-Pugh Class B or C

- Previous treatment with yttrium-90 spheres

- Clinically significant (ie, symptomatic) peripheral vascular disease

- Substance abuse or medical, psychological, or social conditions that may interfere
with the patient's participation in the study or evaluation of the study results

- Known or suspected allergy to the investigational agents or any agent given in
association with this trial

- Patients unable to take oral medication, requiring intravenous alimentation, who have
malabsorption syndrome or any other conditions affecting gastrointestinal absorption,
or who have active peptic ulcer disease

- Any condition that is unstable or which could jeopardize the safety of the patient
and his/her compliance in the study

- Pregnant or breastfeeding patients. Women of childbearing potential must have a
negative urine pregnancy test performed within 7 days prior to the start of study
drug (assessed locally). Both men and women enrolled in this trial must use adequate
barrier birth control measures during the course of the trial.

- Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

- Patients with viral diseases (eg, varicella, herpes zoster); tuberculous or
syphilitic processes in the areas to be treated; and hypersensitivity to the active
substances or to any of the excipients will not be included into the HFSR study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

For subjects randomized into HFSR study subgroup: overall HFSR incidence in the first 3 weeks of sorafenib treatment

Outcome Time Frame:

18 month

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Taiwan: Food and Drug Administration, Department of Health

Study ID:




Start Date:

August 2010

Completion Date:

June 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Sorafenib
  • Hepatocellular Carcinoma (HCC)
  • Carcinoma
  • Carcinoma, Hepatocellular