Actively Recruiting
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
Led by Seoul National University Hospital · Updated on 2025-04-23
30
Participants Needed
4
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis (Vp1-Vp3) and who maintain good liver function.
CONDITIONS
Official Title
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 and over
- Diagnosed with unilobar hepatocellular carcinoma confirmed by histology or imaging (LI-RADS 4 or 5)
- At least one measurable tumor lesion larger than 10 mm on CT or MRI
- Localized portal vein invasion in one liver lobe (Vp1-3) confirmed by CT or MRI
- No cancer spread outside the liver on lung CT and abdominal CT or MRI
- No previous treatment for liver cancer
- Child-Pugh class A liver function
- ECOG performance status of 0 or 1
- No serious dysfunction of major organs based on blood tests within one month before enrollment, including:
- Leukocytes between 2,500 and 12,000 per microliter
- Absolute neutrophil count 1,500 per mm3 or higher
- Hemoglobin 8.0 g/dL or higher (transfusions allowed)
- Total bilirubin 3.0 mg/dL or lower
- Platelets 50,000 per microliter or higher
- INR 2.0 or lower for patients not on anticoagulants
- AST 200 IU/L or lower
- ALT 200 IU/L or lower
- ALP 575 IU/L or lower
- Creatinine 2.0 mg/dL or lower
- Life expectancy longer than 3 months
- Able to understand the clinical trial and provide written consent
- Female participants of childbearing age must confirm they are not pregnant
You will not qualify if you...
- Unsuitable for ablative radioembolization based on pre-treatment 99mTc-MAA scan, including:
- Radiation dose to tumor exceeding lung dose limit of 25 Gy
- Severe hepatic artery to portal vein shunting causing radiation to non-tumorous liver lobe
- Volume of non-tumorous liver outside treatment area less than 30% of total non-tumorous liver
- Presence of hepatic vein or bile duct invasion on imaging
- Scheduled to receive immunotherapy regardless of response to radioembolization
- Active cancer within two years prior to enrollment
- Previous surgery or procedures involving the bile duct
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
National Cancer Center
Ilsan, Gyeonggi-do, South Korea, 10408
Actively Recruiting
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
3
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
4
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Jin Woo Choi, MD, PhD
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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