About this trial
To assess 1-year recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) who are at high risk of Inguinal orchiectomy recurrence usingTACE combined with icaritin
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subjects voluntarily cooperated with the study and signed the informed consent,
Male or female, 18 years old ≤ age ≤75 years old,
The histopathologic diagnosis was hepatocellular carcinoma
R0 resection was performed within 4 to 8 weeks before recruitment (patients who were confirmed to have R0 resection by imaging and pathological examination were excluded from the study group if the residual R1, residual R2 or the margin of resection were not clear)
Disqualifiers
Known sarcomatoid hepatocellular carcinoma/mixed hepatocellular carcinoma-cholangiocarcinoma/fibrolamellar hepatocellular carcinoma;
A history of other malignancies in the past 5 years or at the same time;
Severe functional impairment of other important organs such as heart, brain, lung and kidney;
Patients with a history of immunodeficiency or autoimmune disease;
Trial design
Single group
Treatments tested in this trial
TACE combined with Acoradine
DrugTranscatheter hepatic arterial chemoembolization (TACE) : the treatment interval was 28 days, the window period was ± 7 days. Subjects received a maximum of 4 TACE treatments; reduced and delayed treatment: laboratory tests were performed before the start of each cycle of TACE, with investigator criteria confirming whether TACE treatment was feasible. Acoradine: 6 tablets bid, taken after meals for 6 months or until intolerable or progressive disease (starting one month after surgery) .
Treatment groups
Trial outcomes
Primary outcomes
1 year recurrence-free survival rate ,1-year RFSR.
1 year recurrence-free survival rate ,1-year RFSR.
Secondary outcomes
TTR( time to recurrence)
TTR( time to recurrence)
Sponsors and contacts
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