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

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 (NCT06644937) is a Phase 2 / Phase 3 interventional studying Hepatocellular Carcinoma (HCC), sponsored by Zhujiang Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatocellular Carcinoma (HCC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The subjects voluntarily cooperated with the study and signed the willing to sign a consent form, 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) Who Should NOT Join This Trial: 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 weakened immune system or autoimmune conditions (where your immune system attacks your own body); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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;

Treatments Being Tested

DRUG

TACE combined with Acoradine

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) .

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06644937), the sponsor (Zhujiang Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06644937 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06644937?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06644937?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06644937. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06644937. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.