To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
Sorafenib 800 mg/day orally
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGProgression-free survival (PFS) rate
Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, 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
Radiologic response rate
Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Time frame: at 12 weeks after randomization
Overall patient survival rate
The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Time frame: up to 2 years after randomization
Objective response rate
Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Time frame: at 12 weeks and up to 2 years after randomization
Disease control rate
Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Time frame: at 12 weeks and up to 2 years after randomization
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