Hepatocellular Carcinoma (HCC)
Conditions
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, 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.
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate by mRECIST | up to 1 year | the proportion of CR by mRECIST at any time of the primary target tumor |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate | up to 1 year |
| local progression-free survival | 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 | 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 | From date of radioembolization until the date of death from any cause, assessed up to 60 months |
Countries
South Korea
Contacts
CONTACTHyo-Cheol Kim, MD
Outcome results
None listed