Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC
|ClinicalTrials.gov Identifier: NCT00576056|
Recruitment Status : Terminated (Bayer Healthcare is no supplying the study drug)
First Posted : December 18, 2007
Results First Posted : December 28, 2016
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: Sorafenib Drug: TACE||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Transcatheter Arterial Chemoembolization (TACE) Plus Oral Sorafenib (BAY 43-9006, Nexavar®) for Unresectable Hepatocellular Carcinoma (HCC)|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Tace and Sorafenib
Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
Other Name: NexavarDrug: TACE
TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.
Other Name: Transarterial Chemoembolization
- Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality [ Time Frame: Up to 24 months (from initial treatment through 12 months follow-up) ]Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
- Determine the Overall Survival in Patients Treated With This Combination Regimen [ Time Frame: From date of initial treatment until the date of death from any cause ]Overall survival (OS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of death. For a surviving patient, OS is censored by the last follow-up date when that patient is documented to be alive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576056
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Thomas C Gamblin, MD||University of Pittsburgh|