Same-day Radioembolization for Large HCC

Official title

Same-day Radioembolization for Large HCC (>5cm) With Y90 Resin Microspheres : Multicenter Prospective Registry Study

Overview

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.

Detailed description

SIR-Spheres (SIRTEX): A mother vial containing ≥7 GBq is delivered to the hospital, and the treatment team divides it into daughter vials with specific radiation activities tailored to the target vessels. This allows for same-day TARE, in which lung shunt evaluation, vessel identification, dose calculation, and microsphere injection are all conducted on the same day.

This approach is referred to as same-day TARE.

To implement same-day TARE effectively, it is crucial to carefully select patients who are expected to have a low lung shunt fraction. This helps minimize the waste of pre-ordered SIR-Spheres vials that would otherwise go unused. Factors associated with a high lung shunt fraction include large tumor size, hepatic vein invasion, the presence of a transjugular intrahepatic portosystemic shunt (TIPS), and dysmorphic intratumoral vessels. In patients with tumors larger than 5 cm, the lung shunt fraction is likely to be low if there is no hepatic vein invasion, no TIPS, and no dysmorphic intratumoral vessels. Therefore, by selecting patients without dysmorphic intratumoral vessels for same-day TARE, it is possible to avoid wasting SIR-Spheres vials and perform the procedure without delays in treatment.

Furthermore, by defining safe and effective dose ranges for lung dose, tumor dose, and perfused liver dose, a standardized TARE protocol can be established. Through this study, we aim to establish appropriate patient selection criteria for same-day TARE and to standardize TARE dosimetry.

Interventions

• Procedure same-day radioembolization
  On the day of the procedure, angiography is performed, followed by cone-beam CT of the hepatic artery. After injecting 99mTc-MAA into the hepatic artery, the patient is transferred to the nuclear medicine department for a lung shunt scan and lung SPECT/CT. The lung shunt fraction is determined using the planar images. Using diagnostic CT/MRI and 99mTc-MAA images, the treatment dose is calculated with the multi-compartment MIRD method. The acceptable range for tumor absorbed dose is ≥100 Gy, and

Primary outcome measures

• percentage of execution of same-day radioembolization procedure [Time frame: Day 1]

Secondary outcome measures (4)

• Objective response rate [Time frame: up to 1 year]
• local progression-free survival [Time frame: From date of radioembolization until the date of first documented progression of treated tumor or date of death from any cause, whichever came first, assessed up to 60 months]
• Progression-free survival [Time frame: From date of radioembolization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
• overall survival [Time frame: From date of radioembolization until the date of death from any cause, assessed up to 60 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

South Korea · 4 centers

• National Cancer Center — Goyang
• Samsung Medical Center — Seoul
• Seoul National University Hospital — Seoul
• Severance hospital — Seoul

Publications

• Kim 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
• Choi 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

Identifiers

NCT: NCT06944483 · 2503-051-1620

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗