Clinical trial · Interventional
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
An Open-label, Prospective, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Ablative Radioembolization Using Yttrium-90 Glass Microspheres in Patients With Locally-advanced Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablative radioembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radioembolization
- description
- Hepatocellular carcinoma with localized portal vein tumor thrombosis (Vp1-Vp3) will be treated by ablative radioembolization using TheraSphere (Boston Scientific) glass microspheres
- interventionNames
- Procedure: Ablative radioembolization
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Secondary outcomes (23)
- measure
- Objective response rate according to mRECIST
- timeFrame
- Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults aged 18 and over 2. Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5) 3. Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI 4. Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI 5. Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI 6. Patients with no prior treatment for liver cancer 7. Child-Pugh class A 8. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less 9. Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment 1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL 2. Absolute neutrophil count ≥ 1,500/mm\^3 3. Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion) 4. Total bilirubin ≤ 3.0 mg/dL 5. Platelets ≥ 50,000/µL 6. For patients not on anticoagulants, INR ≤ 2.0 7. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 8. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 9. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit) 10. Creatinine ≤ 2.0 mg/dL 10. Patients with a life expectancy of more than 3 months 11. Patients who have fully understood the clinical trial and given written consent 12. Female patients of childbearing age confirmed not to be pregnant Exclusion Criteria: 1. Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization. 1. 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. 2. Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe. 2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume. 3. Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI. 4. Patients scheduled to use immunotherapy regardless of the response to radioembolization. 5. Patients who had active cancer within two years prior to joining the clinical trial. 6. Patients who have undergone surgery or procedures related to the bile duct. 7. Pregnant or breastfeeding women.
References
Publications (1)
- DERIVEDChoi JW, Kim GM, Hyun D, Jang MJ, Kim HC. Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma with Localized Portal Vein Tumor Thrombosis (RESOLVE): Protocol for an Open-label, Multi-center, Single-arm Trial. Cardiovasc Intervent Radiol. 2025 Mar;48(3):398-404. doi: 10.1007/s00270-024-03935-2. Epub 2025 Feb 13. PMID 39948248