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

Inclusion Criteria:

1. The subjects voluntarily cooperated with the study and signed the informed consent,

2. Male or female, 18 years old ≤ age ≤75 years old,

3. The histopathologic diagnosis was hepatocellular carcinoma

4. R0 resection was performed within 4 to 8 weeks before recruitment (patients who wereconfirmed to have R0 resection by imaging and pathological examination were excludedfrom the study group if the residual R1, residual R2 or the margin of resection werenot clear)

5. To satisfy any of the following high risk factors for postoperative recurrence ofhepatocellular carcinoma: I) BCLC stage B (> 3 tumors, regardless of size or number, at least one of whichis > 3 cm in diameter) ; ii) single tumor ≥5 cm in diameter; III) intraoperativeor postoperative pathological findings of vascular invasion (including microvascularinvasion and VP1/VP2 portal vein invasion) ; IV) histopathologic grade of lowdifferentiation; v) capsular invasion or loss with unclear border; VI) directinvasion of adjacent organs

6. ECOG performance status score of 0-1 and Child-Pugh score of 5-6

7. None of the patients had received anti-tumor therapy for hepatocellular carcinoma,including systemic therapy and local therapy (except for 1-2 prophylactic TACE orHAIC 4-8 weeks after radical therapy) .

8. Subjects who received radical therapy, if required, were allowed to receive 1-2prophylactic TACE/Haic treatments 4-8 weeks after surgery (on demand and notnecessarily)

Exclusion Criteria:

1. Known sarcomatoid hepatocellular carcinoma/mixed hepatocellularcarcinoma-cholangiocarcinoma/fibrolamellar hepatocellular carcinoma;

2. A history of other malignancies in the past 5 years or at the same time;

3. Severe functional impairment of other important organs such as heart, brain, lungand kidney;

4. Patients with a history of immunodeficiency or autoimmune disease;

5. Evidence of tumor recurrence or metastasis before enrollment;

6. Known hypersensitivity to active ingredients, excipients, or history of severeallergy to any other monoclonal antibody, anti-angiogenic drugs;

7. Patients with a history of hepatic encephalopathy;