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Recruiting

NCT Number: NCT06979219

Streamlining Radioembolization for Small HCC

In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel, tumor size < 5cm), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center, Goyang, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults aged >18 years
  • Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)
  • hepatocellular carcinoma 5cm or smaller
  • Tumor number is 3 or smaller
  • Dysmorphic intratumoral vessel is absent or smaller than 3 mm
  • 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/MRI
  • Dysmorphic intratumoral vessel ≥3mm
  • Patient with transjugular intrahepatic portosystemic shunt
  • Patient with bilioenteric anastomosis or biliary stent
  • Patient with centrilobular emphysema or interstitial lung disease
  • main portal vein invasion

Treatment and study plan

Primary outcomes

  1. complete response rate by mRECIST

    Time frame: up to 1 year

    the proportion of CR by mRECIST at any time of the primary target tumor

Secondary outcomes

  1. objective response rate

    Time frame: up to 1 year

  2. 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

  3. 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

  4. overall survival

    Time frame: From date of radioembolization until the date of death from any cause, assessed up to 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hyo-Cheol Kim, MD

CONTACT

[email protected]

82-10-5136-5205

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study

Acronym: ISTAR-02

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 18, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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