Hepatocellular Carcinoma (HCC)Phase 2/3NCT06644937
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
A Phase 2/3 study testing TACE combined with Acoradine in people with Hepatocellular Carcinoma (HCC), run by Zhujiang Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- TACE combined with Acoradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2024to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily cooperated with the study and signed the informed consent,
- Male or female, 18 years old ≤ age ≤75 years old,
- The histopathologic diagnosis was hepatocellular carcinoma
- 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)
- To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma:
- 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
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- ECOG performance status score of 0-1 and Child-Pugh score of 5-6
- 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) .
- 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 cannot join
- Known sarcomatoid hepatocellular carcinoma/mixed hepatocellular carcinoma-cholangiocarcinoma/fibrolamellar hepatocellular carcinoma;
- A history of other malignancies in the past 5 years or at the same time;
- Severe functional impairment of other important organs such as heart, brain, lung and kidney;
- Patients with a history of immunodeficiency or autoimmune disease;
- Evidence of tumor recurrence or metastasis before enrollment;
- Known hypersensitivity to active ingredients, excipients, or history of severe allergy to any other monoclonal antibody, anti-angiogenic drugs;
- Patients with a history of hepatic encephalopathy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000
Shunjun Fu, Prof., 15989187352, fsj103@163.com
About this study
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
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- TACE combined with Acoradine
- Keywords
- hepatocellular carcinoma, RFS, adjuvant therapy after surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE combined with AcoradineDrug
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) .
| Study group | Role | What they receive |
|---|---|---|
| TACE combination with icaritin | Experimental | Not described Receives: Drug: TACE combined with Acoradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year recurrence-free survival rate ,1-year RFSR.
1 year recurrence-free survival rate ,1-year RFSR.
Measured: 1 year
Secondary outcomes (1)
TTR( time to recurrence)
TTR( time to recurrence)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start29 Nov 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644937
- Sponsor's protocol ID
- 2024-KY-281-01
- Status last verified
- Sep 2024
- First submitted
- 14 Oct 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06644937
- Acronym / sponsor ID
- 2024-KY-281-01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, RFS, adjuvant therapy after surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE combination with icaritin | Experimental | Drug: TACE combined with Acoradine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subjects voluntarily cooperated with the study and signed the informed consent,
- Male or female, 18 years old ≤ age ≤75 years old,
- The histopathologic diagnosis was hepatocellular carcinoma
- 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)
- To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma:
Key exclusion criteria (7 listed)
- Known sarcomatoid hepatocellular carcinoma/mixed hepatocellular carcinoma-cholangiocarcinoma/fibrolamellar hepatocellular carcinoma;
- A history of other malignancies in the past 5 years or at the same time;
- Severe functional impairment of other important organs such as heart, brain, lung and kidney;
- Patients with a history of immunodeficiency or autoimmune disease;
- Evidence of tumor recurrence or metastasis before enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE combined with AcoradineTranscatheter 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) . | Drug | TACE combination with icaritin |
Primary outcome
1 year recurrence-free survival rate ,1-year RFSR.
Time frame: 1 year
1 year recurrence-free survival rate ,1-year RFSR.
1 secondary outcome
TTR( time to recurrence)
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TACE combined with Acoradine in people with Hepatocellular Carcinoma (HCC), run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shunjun Fu Fu Shunjun Fu, Prof. (15989187352, fsj103@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year recurrence-free survival rate ,1-year RFSR. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.