Streamlining Radioembolization for Small HCC

Seoul National University Hospital146 enrolled

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, 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.

Study Type

OBSERVATIONAL

Enrollment

146

Conditions

Hepatocellular Carcinoma (HCC)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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: 1. Hepatic vein invasion on CT/MRI 2. Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRI 3. Dysmorphic intratumoral vessel ≥3mm 4. Patient with transjugular intrahepatic portosystemic shunt 5. Patient with bilioenteric anastomosis or biliary stent 6. Patient with centrilobular emphysema or interstitial lung disease 7. main portal vein invasion

Locations (5)

National Cancer Center

Goyang, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

complete response rate by mRECIST

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

Time frame: up to 1 year

Secondary Outcomes

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

Central Contacts

Hyo-Cheol Kim, MD

CONTACT

82-10-5136-5205 radioembolization@snu.ac.kr

Data from ClinicalTrials.gov

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