TACE plus icaritin as adjuvant therapy after surgery for high-risk hepatocellular carcinoma

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

This trial will test whether adding transarterial chemoembolization (TACE) plus oral icaritin after curative liver resection lowers 1-year recurrence in people with high-risk hepatocellular carcinoma.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06644937 on ClinicalTrials.gov

What this trial studies

This is a single-arm, phase 2/3 trial of adjuvant transarterial chemoembolization (TACE) combined with oral icaritin (Acoradine) given after R0 liver resection in patients judged to be at high risk of recurrence. Eligible patients are adults 18–75 who had R0 resection 4–8 weeks before enrollment and meet predefined high-risk criteria such as multiple or large tumors, vascular invasion, poor differentiation, or capsular invasion. The primary outcome is 1-year recurrence-free survival, with patients followed postprocedurally according to the protocol for recurrence and safety. The study is conducted at a single center and uses imaging and pathology to confirm eligibility and recurrence events.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed hepatocellular carcinoma who underwent R0 resection 4–8 weeks earlier and who have high-risk features for recurrence (e.g., multiple/large tumors, vascular invasion, poor differentiation, or capsular invasion).

Not a fit: Patients without high-risk features, those with R1/R2 or unclear surgical margins, decompensated liver disease, or distant metastases are unlikely to benefit from this adjuvant approach.

Why it matters

Potential benefit: If successful, the combination could reduce early postoperative recurrence and extend recurrence-free survival for patients with high-risk HCC.

How similar studies have performed: Previous trials of adjuvant TACE have shown mixed results and icaritin remains investigational, so the specific combination is relatively novel with limited prior clinical evidence of success.

Eligibility criteria

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 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)
5. To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma:

   I) BCLC stage B (\> 3 tumors, regardless of size or number, at least one of which is \> 3 cm in diameter) ; ii) single tumor ≥5 cm in diameter; III) intraoperative or postoperative pathological findings of vascular invasion (including microvascular invasion and VP1/VP2 portal vein invasion) ; IV) histopathologic grade of low differentiation; v) capsular invasion or loss with unclear border; VI) direct invasion 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 or HAIC 4-8 weeks after radical therapy) .
8. Subjects who received radical therapy, if required, were allowed to receive 1-2 prophylactic TACE/Haic treatments 4-8 weeks after surgery (on demand and not necessarily)

Exclusion Criteria:

1. Known sarcomatoid hepatocellular carcinoma/mixed hepatocellular carcinoma-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, lung and 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 severe allergy to any other monoclonal antibody, anti-angiogenic drugs;
7. Patients with a history of hepatic encephalopathy;

Where this trial is running

Guangzhou, Guangdong

• Zhujiang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Shunjun Fu Fu Shunjun Fu, Prof.

Conditions Hepatocellular Carcinoma; hepatocellular carcinoma; RFS; adjuvant therapy after surgery