Actively Recruiting
Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma 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 postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with mFOLFOX in hepatocellular carcinoma with high-risk recurrence factors.
CONDITIONS
Official Title
Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma 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
- Underwent radical surgery within 8 weeks with confirmed negative surgical margins (R0)
- Imaging confirming complete radiological response at least 4 weeks after surgery or ablation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Presence of high-risk factors for HCC recurrence after surgery, including single tumor >5 cm, vascular invasion, multiple tumors (3 or more), high tumor grade (Edmondson III-IV), or surgical margin ≤1 cm
- For patients with elevated preoperative AFP, significant decrease and no upward trend after surgery
- Hepatitis B or C patients must have received and continue standardized antiviral therapy
- Adequate organ and bone marrow function based on specified laboratory criteria
- Life expectancy greater than 12 months
- Not pregnant
You will not qualify if you...
- Presence of extrahepatic metastasis, residual lesions, or recurrence after surgery or ablation
- Received adjuvant therapies like transarterial chemoembolization (TACE) after surgery
- Child-Pugh grade B or C liver function or history of hepatic encephalopathy
- Significant pericardial effusion or symptoms requiring drainage of pleural effusion or ascites
- History of bleeding events within 6 months, including esophageal or gastric variceal bleeding
- Unable to undergo contrast-enhanced liver CT or MRI
- Not eligible for radical surgery
- Use of Chinese herbal medicines with antitumor or immunomodulatory effects within 14 days before enrollment
- Participation in other drug trials within 4 weeks before enrollment
- Co-infection with hepatitis B and C
- History of arterial or venous thromboembolic events within 6 months
- Cardiopulmonary insufficiency
- Severe active infection within 4 weeks before treatment
- Known hypersensitivity to study drugs or history of severe allergic reactions
- History of drug abuse, alcoholism, or substance use
- History of psychiatric disorders with limited capacity for conduct
- Other acute or chronic diseases or abnormal labs that increase risks or interfere with study results according to investigator judgment
AI-Screening
AI-Powered Screening
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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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