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).

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Bayer

Status and phase

Completed
Phase 2

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00855218
12918
2008-005056-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

307 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

307 participants in 2 patient groups, including a placebo group

Sorafenib (Nexavar, BAY43-9006) + TACE
Experimental group
Description:
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Treatment:
Drug: Sorafenib (Nexavar, BAY43-9006)
Placebo + TACE
Placebo Comparator group
Description:
Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Treatment:
Drug: Placebo

Trial contacts and locations

107

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Data sourced from clinicaltrials.gov

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