Streamlining Radioembolization for Small HCC (ISTAR-02)

Seoul National University

Status: Enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other

Identifiers

NCT06979219

2503-052-1620

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HCC can be diagnosed by AASLD guideline
• hepatocellular carcinoma 5cm or smaller
• 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
• biliary stent or bilioenteric anastomosis

Trial design

146 participants in 1 patient group

Streamlining group

Description:

radioembolization is performed without MAA scan