HepatocarcinomaPhase 2NCT06900478
Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC
A Phase 2 study testing Icariin Soft Capsules+TACE in people with Hepatocarcinoma, run by Hua Li at 1 site in China.
Trial summary
This is a prospective, single-center, phase II study，to evaluate the efficacy and safety of icariin soft capsules combined with TACE as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocarcinoma
- What is being tested?
- Icariin Soft Capsules+TACE
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2025to 28 Feb 2027
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years;
- ECOG Performance Status (PS) of 0 or 1;
- Histologically or cytologically diagnosed as HCC
- Fully recovered from surgical resection or ablation prior to enrollment;
- Presence of the following high-risk recurrence factors after resection or ablation: tumor maximum diameter > 5 cm; multiple tumors; microvascular or major vascular invasion; margin distance from the tumor edge < 1 cm; poorly differentiated tumors (Edmondson grade III-IV); lymph node metastasis; persistent abnormal AFP or abnormal prothrombin (DCP);
- Child-Pugh class A5-B7;
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- Expected survival time > 3 months;
- Normal major organ function: Hemoglobin ≥ 80 g/L, Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L, Platelet count ≥ 50 × 10^9/L, Serum albumin ≥ 30 g/L, Total bilirubin ≤ 2 ULN, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤ 2.5 × ULN, Alkaline Phosphatase (ALP) ≤ 2.5 × ULN, Creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 ml/min, International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;
- Negative HIV test results at screening;
- Hepatitis B virus (HBV) DNA<500 IU/mL;
- No major vascular invasion (Vp3 or Vp4) of the portal vein or any level of major vascular invasion of the hepatic veins or inferior vena cava;
- Within 7 days prior to screening, women of childbearing potential must confirm a negative serum pregnancy test and agree to use effective contraception during the study drug administration and for 60 days after the last dose of the study drug;
Who cannot join
- Known cases of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
- HCC recurrence prior to study enrollment;
- Co-infection with HBV and delta hepatitis virus;
- Clinically significant ascites (Note: ascites detectable only through imaging studies are permitted to participate in the study);
- History of hepatic encephalopathy;
- Receipt of any other investigational drug treatment within 4 weeks prior to Day
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- 1 of Cycle 1;
- Presence of abdominal wall fistula, gastrointestinal perforation, refractory non-healing gastric ulcers, or history of active gastrointestinal bleeding within 6 months prior to enrollment;
- History of another malignancy tumor , except for the cured skin basal cell carcinoma and cervical carcinoma in situ)
- Active tuberculosis;
- Functional impairment of major organs (heart, lungs, kidneys, etc.), severe infections, or > grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) version 5.0);
- Very early-stage HCC, solitary tumors, size < 2 centimeters;
- Any allergy to the drugs used in the TACE regimen or known components of epimedium soft capsules;
- History of organ transplantation;
- Pregnant or breastfeeding female patients, or those unwilling to use contraception during the trial;
- Any other diseases, metabolic disorders, abnormal physical examination results, or laboratory test results that raise suspicion of contraindications for the investigational drug, may affect the reliability of study results, or place the patient at high risk for treatment complications, or affect patient compliance.
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
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Hua Li, +86-13060975202, lihua100@yeah.net
About this study
Official title: Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for Hepatocellular Carcinoma With High-Risk Recurrence Factors:A Single-Center, Prospective Study
This is a prospective, single-center, phase II study，to evaluate the efficacy and safety of icariin soft capsules combined with TACE as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.
- Conditions
- Hepatocarcinoma
- Being tested
- Icariin Soft Capsules+TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icariin Soft Capsules+TACEDrug
TACE: perform preoperative infusion chemotherapy, then selectively inject 2 to 5 mL of iodized oil and embolize.
Icariin Soft Capsules：take 6 tablets each time, orally, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Icariin Soft Capsules + TACE | Experimental | TACE treatment was performed one month after surgery, and Icariin Soft Capsules for disease progression or study termination. Receives: Drug: Icariin Soft Capsules+TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival Rate
The proportion of patients who did not experience recurrence or death
Measured: 12 months
Secondary outcomes (2)
Disease Free Survival
DFS defined as the time from date of treatment until the date of recurrence or death due to any cause
Measured: 24 months
Overall survival (OS)
OS defined as the time from date of treatment until the date of death due to any cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Li, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900478
- Sponsor's protocol ID
- 2024-349-02
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for Hepatocellular Carcinoma With High-Risk Recurrence Factors:A Single-Center, Prospective Study
- ClinicalTrials.gov ID
- NCT06900478
- Acronym / sponsor ID
- 2024-349-02
- Conditions
- Hepatocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hua LiUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 28 Mar 2025 (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.
This is a prospective, single-center, phase II study，to evaluate the efficacy and safety of icariin soft capsules combined with TACE as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icariin Soft Capsules + TACE | Experimental | Drug: Icariin Soft Capsules+TACETACE treatment was performed one month after surgery, and Icariin Soft Capsules for disease progression or study termination. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 80 years;
- ECOG Performance Status (PS) of 0 or 1;
- Histologically or cytologically diagnosed as HCC
- Fully recovered from surgical resection or ablation prior to enrollment;
- Presence of the following high-risk recurrence factors after resection or ablation: tumor maximum diameter > 5 cm; multiple tumors; microvascular or major vascular invasion; margin distance from the tumor edge < 1 cm; poorly differentiated tumors (Edmondson grade III-IV); lymph node metastasis; persistent abnormal AFP or abnormal prothrombin (DCP);
Key exclusion criteria (16 listed)
- Known cases of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
- HCC recurrence prior to study enrollment;
- Co-infection with HBV and delta hepatitis virus;
- Clinically significant ascites (Note: ascites detectable only through imaging studies are permitted to participate in the study);
- History of hepatic encephalopathy;
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 |
|---|---|---|
| Icariin Soft Capsules+TACETACE: perform preoperative infusion chemotherapy, then selectively inject 2 to 5 mL of iodized oil and embolize. Icariin Soft Capsules：take 6 tablets each time, orally, twice a day. | Drug | Icariin Soft Capsules + TACE |
Primary outcome
Recurrence Free Survival Rate
Time frame: 12 months
The proportion of patients who did not experience recurrence or death
2 secondary outcomes
Disease Free Survival
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
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 28 Mar 2025.
- Individual participant dataSharing planned: No
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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 study testing Icariin Soft Capsules+TACE in people with Hepatocarcinoma, run by Hua Li 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 12 inclusion and 16 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: opening soon, as of the sponsor's last update on 28 Mar 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 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.
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 Hua Li (+86-13060975202, lihua100@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival Rate (time frame: 12 months). 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 28 Mar 2025.