Hepatocellular Carcinoma (HCC)Phase 2NCT07337460
Efficacy and Safety of Icaritin Combined With mFOLFOX in Postoperative HCC With High-risk Recurrence Factors
A Phase 2 study testing Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil in people with Hepatocellular Carcinoma (HCC), run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
This is a single-center, single-arm, prospective trial to explore the efficacy and safety of Icaritin Soft Capsules combined with postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with Modified Folinic acid, Fluorouracil, and Oxaliplatin (mFOLFOX) in hepatocellular carcinoma (HCC) with high-risk… 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?
- Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Jan 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤75 years.
- Histologically/cytologically confirmed hepatocellular carcinoma (HCC) (fibrotic HCC and mixed HCC/biliary carcinoma subtypes were excluded from inclusion criteria), with no prior treatment for HCC (including but not limited to chemotherapy, targeted therapy, immunotherapy, cell therapy, local radiotherapy, and interventional therapy) before surgery.
- Patients who underwent radical surgery within the first 8 weeks and meet the following criteria: a. Histologically confirmed negative surgical margins (R0) for radical surgery: 1) No residual cancer on gross intraoperative or postoperative imaging; 2) Liver margins>1cm from tumor boundary, or margins ≤1cm with no tumor cell remnants in resected pathological tissue; b. Imaging examination (enhanced chest CT, abdominal CT or MRI, pelvic CT or MRI) performed ≥4 weeks after surgical resection or ablation to confirm complete radiological response.
- ECOG score ranges from 0 to 1.
- Patients meeting any of the following high-risk factors for hepatocellular carcinoma recurrence after radical surgery: 1) Single tumor>5 cm 2) Concurrent vascular invasion (microvascular invasion or major vessel invasion Vp1-2) 3) Multiple lesions with ≥3 tumors 4) Tumor grade Edmondson III-IV 5) Surgical margin ≤1cm
- For patients with preoperative AFP elevation, post-radical surgery or ablation, AFP levels must have significantly decreased and show no significant upward trend.
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- Subjects with Hepatitis B or C Virus(HBV or HCV) infection must undergo standardized antiviral therapy prior to enrollment and continue the treatment during the study period.
- The patient must have adequate organ and bone marrow function, with laboratory test values meeting the following criteria: 1) Complete blood count (CBC): Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L; hemoglobin (Hb) ≥90 g/L; 2) Liver function: Serum totalbilirubin (TBIL) ≤2×upper limit of normal (ULN), or direct bilirubin ≤ULN for subjects with TBIL>2×ULN; alanineaminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; serum albumin ≥28 g/L; 3) Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance (CCr) ≥45 mL/min (Cockcroft-Gault formula) for subjects with Cr>1.5×ULN; 4) Urinalysis shows urine protein <2+; For subjects with baseline urinalysis showing proteinuria ≥2+ in routine urine tests, 24-hour urine collection should be performed with 24-hour urine protein quantification <1g; 5) Coagulation function: International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤1.5×Upper Limit of Normal (ULN).
- Life expectancy exceeding 12 months.
- Not pregnant.
Who cannot join
- Presence of extrahepatic metastasis, residual lesions, or recurrence on imaging after surgery or ablation.
- Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery.
- Child-Pugh classification grade B or C, or a history of hepatic encephalopathy.
- Presence of clinically significant pericardial effusion; or clinical symptoms requiring drainage of pleural effusion or ascites.
- History of bleeding events within 6 months prior to enrollment, such as esophageal or gastric variceal bleeding caused by portal hypertension. Subjects with esophageal or gastric varices requiring intervention within 28 days before enrollment. Untreated or inadequately treated esophageal or gastric varices deemed by investigators to pose a high risk of bleeding.
- The subject is unable to undergo contrast-enhanced liver CT or MRI scans.
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- Patients who do not meet the criteria for radical surgery.
- Received Chinese herbal medicine or Chinese patent medicine with antitumor indications or immunomodulatory drugs (including systemic use of thymosin, interferon, etc.) within 14 days prior to enrollment.
- Participation in other drug clinical trials within 4 weeks prior to enrollment.
- Co-infection with HBV and HCV (defined as HCV infection history with negative HCV RNA, which was considered as non-infection in this study).
- History of arterial or venous thromboembolic events occurring within 6 months prior to enrollment, including myocardial infarction (MI), unstable angina, cerebrovascular accident or transient ischemic attack (TIA), pulmonary embolism (PE), deep vein thrombosis (DVT), or any other severe thromboembolic event.
- Patients with cardiopulmonary insufficiency.
- Severe infection in the active phase or with poor clinical control. A severe infection within 4 weeks prior to the first treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications.
- Known hypersensitivity to any investigational drug ingredients; or a history of severe allergic reactions to other traditional Chinese patent medicines.
- Known history of drug abuse, alcoholism, or substance use.
- Individuals with a history of psychiatric disorders and lacking capacity for conduct or having limited capacity for conduct.
- Other acute or chronic diseases, mental disorders, or abnormal laboratory test results that may lead to the following outcomes: increased risks for the subject to participate in the study or receive study treatment, interference with the interpretation of study results, or, at the investigator's discretion, that participation in the study is not in the subject's best interest.
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
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
Dou-sheng Bai, +86051487373382, drbaidousheng@yzu.edu.cn
Guo-Qing Jiang, +86051487373382, drbaidousheng@yzu.edu.cn
About this study
Official title: Icaritin Soft Capsules Combined With Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in HCC With High-risk Recurrence Factors: A Single-center, Phase II, Single-arm, Prospective Study
This is a single-center, single-arm, prospective trial to explore the efficacy and safety of Icaritin Soft Capsules combined with postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with Modified Folinic acid, Fluorouracil, and Oxaliplatin (mFOLFOX) in hepatocellular carcinoma (HCC) with high-risk recurrence factors.
Read the detailed description
Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Patients enrolled in this study received a first HAIC treatment (mFOLFOX-HAIC) 4-8 weeks after radical surgery. Within two weeks after the first HAIC procedure, patients should begin taking 2400mg of Icaritin Soft Capsules twice daily for three months, with the total treatment duration not exceeding one year. A second HAIC session was administered 3 weeks later, depending on individual patient conditions, with a maximum of two treatments. The protocol specified: Oxaliplatin 85 mg/m²via arterial infusion for 2-3 hours, leucovorin calcium 400 mg/m² for 1-2 hours, followed by a 400 mg/m²arterial infusion of 5-fluorouracil for 5 minutes , and continuous arterial infusion at 2400 mg/m²for 46 hours.
Follow-up was conducted every 8-12 weeks until 12 months postoperatively or the termination of the study. The follow-up included the patient's survival status, tumor recurrence, adverse drug reactions,living quality, routine blood tests, liver function, and electrocardiogram.Contrast-enhanced abdominal CT (layer thickness ≤5 mm) or contrast-enhanced MRI (including DWI sequence) were used for tumor recurrence.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil
- Keywords
- Hepatocellular Carcinoma, postoperative adjuvant chemoinfusion, recurrence
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracilDrug
Postoperative adjuvant transarterial chemoinfusion with mFOLFOX.mFOLFOX-HAIC: Oxaliplatin 85 mg/m²via arterial infusion for 2-3 hours, leucovorin calcium 400 mg/m² for 1-2 hours, followed by a 400 mg/m²arterial infusion of 5-fluorouracil for 5 minutes , and continuous arterial infusion at 2400 mg/m²for 46 hours.Within two weeks after the first HAIC procedure, patients should begin taking 2400mg of Icaritin Soft Capsules twice daily for three months, with the total treatment duration not exceeding one year.A second HAIC session was administered 3 weeks later, depending on individual patient conditions, with a maximum of two treatments.
| Study group | Role | What they receive |
|---|---|---|
| Icaritin Soft Capsules and mFOLFOX-HAIC | Experimental | Treatment:Icaritin Soft Capsules and postoperative adjuvant transarterial chemoinfusion with mFOLFOX Receives: Drug: Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Recurrence-free survival
Measured: 2 years
Secondary outcomes (4)
Overall survival (OS)
Overall survival
Measured: 2 years
Time to recurrence (TTR)
Time to recurrence
Measured: 2 years
Safety:treatment-related adverse events (AE) rates
Safety:treatment-related adverse events (AE) rates
Measured: 2 years
living quality
Patient quality of life was evaluated with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire- Hepatocellular Carcinoma 18(EORTC QLQ-HCC18 )scale.Standardized scores (range: 0-100) were calculated, where increased scores correspond to worse outcomes (i.e., more severe symptoms or impaired quality of life)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Nov 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jan 2028 (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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dousheng Bai, Northern Jiangsu People's Hospital
- Investigators
- Dou-sheng Bai, Study chair, Clinical Medical College, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337460
- Sponsor's protocol ID
- 2025ky300
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icaritin Soft Capsules Combined With Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in HCC With High-risk Recurrence Factors: A Single-center, Phase II, Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT07337460
- Acronym / sponsor ID
- 2025ky300
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma, postoperative adjuvant chemoinfusion, recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Jan 2026 (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 single-center, single-arm, prospective trial to explore the efficacy and safety of Icaritin Soft Capsules combined with postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with Modified Folinic acid, Fluorouracil, and Oxaliplatin (mFOLFOX) in hepatocellular carcinoma (HCC) with high-risk recurrence factors.
Detailed description
Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Patients enrolled in this study received a first HAIC treatment (mFOLFOX-HAIC) 4-8 weeks after radical surgery. Within two weeks after the first HAIC procedure, patients should begin taking 2400mg of Icaritin Soft Capsules twice daily for three months, with the total treatment duration not exceeding one year. A second HAIC session was administered 3 weeks later, depending on individual patient conditions, with a maximum of two treatments. The protocol specified: Oxaliplatin 85 mg/m²via arterial infusion for 2-3 hours, leucovorin calcium 400 mg/m² for 1-2 hours, followed by a 400 mg/m²arterial infusion of 5-fluorouracil for 5 minutes , and continuous arterial infusion at 2400 mg/m²for 46 hours.
Follow-up was conducted every 8-12 weeks until 12 months postoperatively or the termination of the study. The follow-up included the patient's survival status, tumor recurrence, adverse drug reactions,living quality, routine blood tests, liver function, and electrocardiogram.Contrast-enhanced abdominal CT (layer thickness ≤5 mm) or contrast-enhanced MRI (including DWI sequence) were used for tumor recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icaritin Soft Capsules and mFOLFOX-HAIC | Experimental | Drug: Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracilTreatment:Icaritin Soft Capsules and postoperative adjuvant transarterial chemoinfusion with mFOLFOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤75 years.
- Histologically/cytologically confirmed hepatocellular carcinoma (HCC) (fibrotic HCC and mixed HCC/biliary carcinoma subtypes were excluded from inclusion criteria), with no prior treatment for HCC (including but not limited to chemotherapy, targeted therapy, immunotherapy, cell therapy, local radiotherapy, and interventional therapy) before surgery.
- Patients who underwent radical surgery within the first 8 weeks and meet the following criteria: a. Histologically confirmed negative surgical margins (R0) for radical surgery: 1) No residual cancer on gross intraoperative or postoperative imaging; 2) Liver margins>1cm from tumor boundary, or margins ≤1cm with no tumor cell remnants in resected pathological tissue; b. Imaging examination (enhanced chest CT, abdominal CT or MRI, pelvic CT or MRI) performed ≥4 weeks after surgical resection or ablation to confirm complete radiological response.
- ECOG score ranges from 0 to 1.
- Patients meeting any of the following high-risk factors for hepatocellular carcinoma recurrence after radical surgery: 1) Single tumor>5 cm 2) Concurrent vascular invasion (microvascular invasion or major vessel invasion Vp1-2) 3) Multiple lesions with ≥3 tumors 4) Tumor grade Edmondson III-IV 5) Surgical margin ≤1cm
Key exclusion criteria (17 listed)
- Presence of extrahepatic metastasis, residual lesions, or recurrence on imaging after surgery or ablation.
- Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery.
- Child-Pugh classification grade B or C, or a history of hepatic encephalopathy.
- Presence of clinically significant pericardial effusion; or clinical symptoms requiring drainage of pleural effusion or ascites.
- History of bleeding events within 6 months prior to enrollment, such as esophageal or gastric variceal bleeding caused by portal hypertension. Subjects with esophageal or gastric varices requiring intervention within 28 days before enrollment. Untreated or inadequately treated esophageal or gastric varices deemed by investigators to pose a high risk of bleeding.
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 |
|---|---|---|
| Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracilPostoperative adjuvant transarterial chemoinfusion with mFOLFOX.mFOLFOX-HAIC: Oxaliplatin 85 mg/m²via arterial infusion for 2-3 hours, leucovorin calcium 400 mg/m² for 1-2 hours, followed by a 400 mg/m²arterial infusion of 5-fluorouracil for 5 minutes , and continuous arterial infusion at 2400 mg/m²for 46 hours.Within two weeks after the first HAIC procedure, patients should begin taking 2400mg of Icaritin Soft Capsules twice daily for three months, with the total treatment duration not exceeding one year.A second HAIC session was administered 3 weeks later, depending on individual patient conditions, with a maximum of two treatments. | Drug | Icaritin Soft Capsules and mFOLFOX-HAIC |
Primary outcome
Recurrence-free survival (RFS)
Time frame: 2 years
Recurrence-free survival
4 secondary outcomes
Overall survival (OS)
Time frame: 2 years
Time to recurrence (TTR)
Time frame: 2 years
Safety:treatment-related adverse events (AE) rates
Time frame: 2 years
living quality
Time frame: 3 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 13 Jan 2026.
- 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.
Dou-sheng Bai study chair
Clinical Medical College, Yangzhou University
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 Icaritin Soft Capsules and mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil in people with Hepatocellular Carcinoma (HCC), run by Northern Jiangsu People's 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 10 inclusion and 17 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 13 Jan 2026. 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 Dou-sheng Bai (+86051487373382, drbaidousheng@yzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: 2 years). 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 13 Jan 2026.