New combo therapy aims to stop liver cancer recurrence in High-Risk patients
NCT ID NCT06644937
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether combining a liver-directed procedure (TACE) with the drug icaritin can help prevent liver cancer from coming back after surgery in patients at high risk of recurrence. Thirty adults who had their liver cancer completely removed will receive up to 4 TACE treatments plus 6 months of icaritin pills. The main goal is to see how many patients remain cancer-free after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Icaritin (Acoradine) combined with transcatheter arterial chemoembolization (TACE)
- What this could lead to
- If it works, this could offer a new way to delay or prevent liver cancer from coming back after surgery in patients at high risk.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply broadly. The combination treatment also carries risks from both TACE and icaritin, and may not improve recurrence rates.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhujiang Hospital, Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510000, China
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