Single-arm Clinical Trial of TACE in Combination With Icaritin as Adjuvant Therapy After Surgery in Patients With Hepatocellular Carcinoma at High Risk of Recurrence

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhujiang Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • TACE combined with Acoradine

    Drug

    Transcatheter 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

30 Participants
are divided into 1 treatment group
Group A: TACE combination with icaritinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1 year recurrence-free survival rate ,1-year RFSR.

1 year recurrence-free survival rate ,1-year RFSR.

Time frame
1 year

Secondary outcomes

1

TTR( time to recurrence)

TTR( time to recurrence)

Time frame
1year

Other outcomes

Sponsors and contacts

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