Actively Recruiting
Efficacy and Safety of Icaritin Combined With mFOLFOX in Postoperative HCC With High-risk Recurrence Factors
Led by Northern Jiangsu People's Hospital · Updated on 2026-01-13
30
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Icaritin Combined With mFOLFOX in Postoperative HCC With High-risk Recurrence Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC), excluding fibrotic HCC and mixed HCC/biliary carcinoma subtypes
- No prior treatment for HCC before surgery
- Radical surgery performed within 8 weeks with confirmed negative surgical margins (R0)
- Imaging confirming complete radiological response at least 4 weeks after surgery
- ECOG performance status of 0 or 1
- Presence of high-risk recurrence factors: single tumor larger than 5 cm, vascular invasion, 3 or more tumors, tumor grade Edmondson III-IV, or surgical margin 1 cm or less
- For patients with elevated preoperative AFP, levels must have decreased significantly post-surgery with no rising trend
- Hepatitis B or C infection patients must be on standardized antiviral therapy before and during the study
- Adequate organ and bone marrow function based on laboratory tests
- Life expectancy greater than 12 months
- Not pregnant
You will not qualify if you...
- Presence of extrahepatic metastasis, residual lesions, or recurrence after surgery
- Previous adjuvant therapies such as transarterial chemoembolization (TACE) after surgery
- Child-Pugh grade B or C or history of hepatic encephalopathy
- Significant pericardial effusion or symptoms requiring drainage of pleural effusion or ascites
- History of bleeding events related to portal hypertension within 6 months
- Untreated or high-risk esophageal or gastric varices
- Inability to undergo contrast-enhanced liver CT or MRI
- Not eligible for radical surgery
- Recent use (within 14 days) of antitumor Chinese herbal or immunomodulatory drugs
- Participation in other drug trials within 4 weeks
- Co-infection with both hepatitis B and C viruses
- History of thromboembolic events within 6 months
- Cardiopulmonary insufficiency
- Severe active infections within 4 weeks prior to treatment
- Known allergy to study drugs or severe allergic reactions to traditional Chinese medicines
- History of drug abuse, alcoholism, or substance use
- Psychiatric disorders affecting capacity to consent or comply
- Other acute or chronic diseases or laboratory abnormalities that increase study risk or interfere with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, China, 225001
Actively Recruiting
Research Team
D
Dou-sheng Bai
CONTACT
G
Guo-Qing Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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