Actively Recruiting
Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Led by Next Biomedical Co., Ltd. · Updated on 2024-11-14
150
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study was to prospectively collect clinical data from patients who underwent hepatic artery chemoembolization using microspheres with different degradation times (2 hours, 1 day, 2 weeks) based on standard treatment.
CONDITIONS
Official Title
Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 19 to 79 years
- Signed informed consent form
- Diagnosed with hepatocellular carcinoma by AASLD criteria confirmed by MRI, CT scan, or biopsy
- Not eligible for amputation, percutaneous resection, or liver transplantation at enrollment
- Child-Pugh class A or B liver function
- Tumor lesion size between 1 cm and 10 cm
- Number of tumors between 1 and 7
- Physical activity status (ECOG) 1 or less without vascular involvement
- Ability to be followed until study completion with life expectancy of 6 months or longer
You will not qualify if you...
- Under 19 years old
- Chronic kidney disease grade 4 or 5
- Previous or current treatment with chemotherapy, radiation therapy, sorafenib, or drug release chemoembolization
- Pregnant, lactating, pre-menopausal women not using effective contraception
- ECOG performance status greater than 1
- Child-Pugh class C liver function
- Advanced hepatocellular carcinoma with vascular invasion or metastasis outside the liver
- Active gastrointestinal bleeding or irreversible bleeding disorders
- Medically uncontrolled encephalopathy or ascites
- Contraindications to MRI, CT scan, angiography, cisplatin chemotherapy, or hepatic artery embolization
- Allergy to contrast media not manageable by prevention
- Extensive portosystemic shunts or reversed portal blood flow
- Serum bilirubin greater than 3.0 mg/dL
- Serum creatinine greater than 2.0 mg/dL
- Any other condition judged by investigators to make participation difficult
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Actively Recruiting
Research Team
J
Jin Hee Maeng, MS
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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