To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels
Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Trans-arterial chemoembolization (TACE) every 6 weeks + external beam radiation therapy starting within 3 weeks after first TACE
Sorafenib 800 mg/day orally
Asan Medical Center
Seoul, South Korea
Progression-free survival (PFS) rate
Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
Time frame: at 12 weeks after randomization
Progression-free survival (PFS) rate
Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Time frame: at 24 weeks and up to 4 years after randomization
Radiologic response rate
Radiologic response rate by independent radiologic review according to RECIST criteria (version 1.1), , assessed by Chi-square test or Fisher's exact test, as appropriate.
Time frame: at 12 and 24 weeks after randomization
treatment-crossover rate
Crossover of treatment is permitted after confirming the disease progression during the initially assigned treatment, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Time frame: at 12 and 24 weeks after randomization
time to progression
The median time to progression assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Time frame: up to 4 years after randomization
Overall patient survival rate
The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
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Time frame: up to 4 years after randomization
Exploratory analysis for overall patient survival rate
By using Cox proportional hazards model to evaluate the interaction between important baseline characteristics and the effect of treatments on overall survival.
Time frame: up to 4 years after randomization