This is a phase 3, multicentri, randomised, open label study. The purpose is to investigate the safety and efficacy of stereotactic body radiation therapy (SBRT) combined with transarterial chemoembolization (TACE) and lenvatinib (LEN) in the treatment of advanced hepatocellular carcinoma with portal vein tumor thrombus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients \<60kg, and 12 mg qd for patients ≥ 60kg)
TACE will be performed one day after oral administration of lenvatinib. Either cTACE or DEB-TACE can be used, depending on the condition of each center.
SBRT will be given within 3 weeks after the first TACE with linear accelerator-based photon beams. Gross tumor volume is defined as intrahepatic tumor and vascular invasion including a 1-cm margin into the contiguous HCC. Prescription dose will be 4500-5000 cGy in 5-8 fractions.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Overall Survival (OS)
OS is defined as the time from first treatment to death, regardless of disease recurrence.
Time frame: Up to 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from the first treatment to progression or death.
Time frame: Up to 2 years
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
Time frame: Up to 2 years
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by mRECIST criteria.
Time frame: Up to 2 years
Incidence of Adverse Events (AE)
Incidence of AE is defined as the percentage of patients who suffer adverse events from the first treatment to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Up to 2 years
Time to Progression (TTP)
TTP is defined as the time from the first treatment to progression.
Time frame: Up to 2 years
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