Clinical trial · Observational
Same-day Radioembolization for Large HCC
Same-day Radioembolization for Large HCC (>5cm) With Y90 Resin Microspheres : Multicenter Prospective Registry Study
- 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)
In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.
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 (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| same-day radioembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- same-day group
- description
- planning angiography, MAA scan, and radioembolization was performed in a single day
- interventionNames
- Procedure: same-day radioembolization
Primary outcomes (1)
- measure
- percentage of execution of same-day radioembolization procedure
- timeFrame
- Day 1
- description
- Execution means that planning angiography, MAA scan and radioembolization are performed in a single day. The number same-day radioembolization is divided by total enrolled patient number.
Secondary outcomes (4)
- measure
- Objective response rate
- timeFrame
- up to 1 year
- description
- objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5) * hepatocellular carcinoma 5cm or larger * dysmorphic intratumoral vessels 3mm or smaller * Child-Pugh class A * ECOG 0 or 1 * the following lab should be met. A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (if patient is receiving hemodialysis, no upper limit of creatinine) * Patients with a life expectancy of \>3 mo * Patients who have adequately understood the clinical trial and consented in writing * Nonpregnant women of childbearing potential Exclusion Criteria: * hepatic vein invasion on CT/MRI * Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRII * TIPS * dysmorphic intratumoral vessels \> 3mm * main portal vein invasion * significant COPD or interstitial lung disease * biliary stent or enterobiliary anastomosis
References
Publications (2)
- BACKGROUNDKim HC, Suh M, Paeng JC, Choi JW. Same-Day versus Multiday Planning/Treatment Radioembolization with Yttrium-90 Resin Microspheres in Patients with Liver Cancer >/=5 cm. J Vasc Interv Radiol. 2025 Dec;36(12):2010-2020.e2. doi: 10.1016/j.jvir.2025.08.028. Epub 2025 Aug 27. PMID 40882836
- BACKGROUNDChoi TW, Joo I, Kim HC. Association of dysmorphic intratumoral vessel with high lung shunt fraction in patients with hepatocellular carcinoma. Sci Rep. 2022 Aug 21;12(1):14248. doi: 10.1038/s41598-022-18697-5. PMID 35989374