Health TrialsbyHealthPanel

Streamlining Radioembolization for Small HCC

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

patients with hepatocellular carcinoma who are scheduled for radioembolization

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

146 Participants
are grouped into 1 trial group
Group A: Streamlining group

Trial outcomes

Primary outcomes

1

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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