Status:
COMPLETED
A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Advanced Adult Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This is a randomized, multi-center, open-labeled, phase III study in patients with advanced HCC. A total of 338 patients will be randomized (1:1) into one of the two treatment arms, to receive sorafen...
Detailed Description
The superiority of the Arm C (cTACE+Sorafenib) over the Arm S (Sorafenib) in the OS period will be verified in the ITT set and FAS using a stratified log-rank test. Stratification factors consist of m...
Eligibility Criteria
Inclusion
- To be eligible to participate in the study, patients must meet the following criteria:
- Signed written informed consent
- Clinical or histological diagnosis of HCC based on the guidelines of the Korean Liver Cancer Study Group and the National Cancer Center Korea
- At least one typical enhanced index lesion in the liver that is bi-dimensionally measurable by multiphasic spiral CT scan or dynamic contrast-enhanced MRI, and size of largest tumor is 15 cm or less at enrollment.
- Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) and chest imaging (CT) performed within 4 weeks prior to the treatment initiation:
- Age of at least 20 years.
- ECOG Performance Status of 0, 1 or 2.
- Child-Pugh class A or B (Child-Pugh score ≤ 7).
- Life expectancy of at least 16 weeks.
- Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements (no transfusion, no restoration), conducted within 14 days prior to screening:
- Female patients at least 1 year postmenopausal, surgically sterile or those of childbearing potential must have a negative urine pregnancy test within 14 days prior to the first treatment, and have to use at least one medically acceptable and effective contraceptive method for the last 2 months prior to Screening Visit: methods of effective contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as a barrier method (implant, injectable contraceptives, oral contraceptives, intrauterine contraceptive device), hormonal IUD, sexual abstinence or vasectomized partner.
Exclusion
Key Trial Info
Start Date :
February 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2017
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT01829035
Start Date
February 21 2013
End Date
June 21 2017
Last Update
March 29 2018
Active Locations (1)
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1
National Cancer Center, Korea
Seoul, South Korea