Status:
RECRUITING
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 specificall...
Detailed Description
Patients diagnosed with unilobar hepatocellular carcinoma and localized portal vein tumor thrombosis (Vp1-Vp3), who also exhibit good liver function, will undergo ablative radioembolization with a dos...
Eligibility Criteria
Inclusion
- Adults aged 18 and over
- Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
- Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
- Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
- Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
- Patients with no prior treatment for liver cancer
- Child-Pugh class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment
- Leukocytes ≥ 2,500/µL and ≤ 12,000/µL
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)
- Total bilirubin ≤ 3.0 mg/dL
- Platelets ≥ 50,000/µL
- For patients not on anticoagulants, INR ≤ 2.0
- AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
- ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
- ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)
- Creatinine ≤ 2.0 mg/dL
- Patients with a life expectancy of more than 3 months
- Patients who have fully understood the clinical trial and given written consent
- Female patients of childbearing age confirmed not to be pregnant
Exclusion
- Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
- Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy.
- Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.
- Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
- Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
- Patients scheduled to use immunotherapy regardless of the response to radioembolization.
- Patients who had active cancer within two years prior to joining the clinical trial.
- Patients who have undergone surgery or procedures related to the bile duct.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06166576
Start Date
November 20 2023
End Date
November 30 2027
Last Update
April 23 2025
Active Locations (4)
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1
National Cancer Center
Ilsan, Gyeonggi-do, South Korea, 10408
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
3
Severance Hospital
Seoul, South Korea, 03722
4
Samsung Medical Center
Seoul, South Korea, 06351