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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhujiang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Shunjun Fu Fu Shunjun Fu, Prof.
• Email: fsj103@163.com
• Phone: 15989187352

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.