This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
158
Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.
TACE including conventional TACE (cTACE) and DEB-TACE. Treatment choices are according to the specific condition of each patient and the experience of interventional radiologists.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGRecurrence-free survival
Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.\[0-2 years\] Longer RFS time indicates better prognosis.
Time frame: 2 years
Overall survival
Overall survival indicates the interval between randomization and death.\[0-2years\]Longer OS time indicates better prognosis.
Time frame: 2 years
Time to recurrence
Time to recurrence indicates the interval between randomization and tumor recurrence.\[0-2years\]Longer TTR time indicates better prognosis.
Time frame: 2 years
Severe adverse events
Incidence rate of severe adverse events. \[0-100%\]. lower rate indicates more safety of the treatment
Time frame: 2 years
Quality of life
Questionnaire score of EORTC-QOL. Higher score indicates better quality of life
Time frame: 2 years
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