A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

Bayer307 enrolled

Overview

This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

307

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib (Nexavar, BAY43-9006)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread * Confirmed Diagnosis of HCC: * Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria * HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography \[CT\] scan, Magnetic resonance imaging \[MRI\], or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. * Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria. * Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory * Documentation of original biopsy for diagnosis is acceptable * Child Pugh class A without ascites * Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization: Exclusion Criteria: * Patients on a liver transplantation list or with advanced liver disease as defined below: * Child Pugh B and C * Active gastrointestinal bleeding * Encephalopathy * Ascites * Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.

Locations (107)

Unnamed facility

La Jolla, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

Gainesville, Florida, United States

Unnamed facility

Miami, Florida, United States

Unnamed facility

Outcomes

Primary Outcomes

Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)

TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.