Clinical trial NCT06944483: Same-day Radioembolization for Large HCC
Official title: Same-day Radioembolization for Large HCC (>5cm) With Y90 Resin Microspheres : Multicenter Prospective Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 138
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hepatocellular carcinoma who are scheduled for radioembolization

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* HCC can be diagnosed by AASLD guideline
* 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)

Exclusion Criteria:

* hepatic vein invasion on CT/MRI
* hepatic vein enhancement on arterial phase of CT/MRI
* TIPS
* dysmorphic intratumoral vessels \> 3mm
* main portal vein invasion
* significant COPD or interstitial lung disease

Primary outcomes:
measure: percentage of execution of same-day radioembolization procedure
timeFrame: Day 1
Secondary outcomes:
measure: Objective response rate
timeFrame: up to 1 year
measure: local progression-free survival
timeFrame: 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
measure: Progression-free survival
timeFrame: 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
measure: overall survival
timeFrame: From date of radioembolization until the date of death from any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
citation: 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.