This is an open-label,multi-center ,non-randomized ,single arm exploratory study . This clinical study is an investigator-initiated clinical trial(IIT ). The objective of this study is to evaluate if the addition of hepatic artery infusion chemotherapy (HAIC) and Donafenib after curative resection for hepatocellular carcinoma patients with a solitary tumor≥5 cm and microvascular invasion (MVI) will prevent or delay the recurrence of the disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Oxaliplatin , fluorouracil, and leucovorin
administration of Donafenib
Lei Zhang
Guangzhou, Guangdong, China
2-year cumulative recurrence-free survival rate
This is defined as the length of time (days) that the patient survives since study registration without any signs or symptoms of locoregional HCC assessed by structured clinical and radiological (clinical) follow-up . If at close-out date of the study, there are no signs of locoregional recurrence, the patient will be censored to the date of the most recent follow-up examination. The 2-year cumulative incidence rates will be estimated from the curves and its associated 95% confidence intervals will be calculated.
Time frame: 2-year
1-year recurrence-free survival rate
This is defined as the length of time (days) that the patient survives since study registration without any signs or symptoms of locoregional HCC assessed by structured clinical and radiological (clinical) follow-up . If at close-out date of the study, there are no signs of locoregional recurrence, the patient will be censored to the date of the most recent follow-up examination. The 1-year cumulative incidence rates will be estimated from the curves and its associated 95% confidence intervals will be calculated.
Time frame: 1-year
Disease-free survival
from the date of enrollment to tumor recurrence or Death
Time frame: 2-year
Overall Survival
from the date of enrollment to Death
Time frame: approximately 60 months from first patient first visit
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0
Time frame: 30 days
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