Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06178198

Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

Led by Seoul National University Hospital · Updated on 2025-01-07

30

Participants Needed

1

Research Sites

159 weeks

Total Duration

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AI-Summary

What this Trial Is About

The RESCUE trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of ablative radioembolization using Yttrium-90. This treatment is being investigated as a potential curative approach, as well as a bridging or downstaging strategy for surgery, in patients with large hepatocellular carcinoma (greater than 8 cm) who maintain good liver function.

CONDITIONS

Official Title

Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 and over
  • Diagnosis of hepatocellular carcinoma confirmed by histology or radiology (LI-RADS 4 or 5)
  • No more than five liver lesions with the largest tumor diameter over 8 cm
  • No vascular or bile duct invasion seen on CT or MRI
  • No spread of cancer outside the liver on lung CT and abdominal imaging
  • No prior treatment for liver cancer
  • Child-Pugh class A liver function
  • ECOG performance status of 0 or 1
  • No major organ dysfunction based on recent blood tests including leukocytes, neutrophils, hemoglobin, bilirubin, platelets, INR, liver enzymes, and creatinine within specified limits
  • Life expectancy greater than 3 months
  • Able to understand and consent to the study
  • Women of childbearing potential must not be pregnant
Not Eligible

You will not qualify if you...

  • Unsuitable for ablative radioembolization due to pre-treatment lung dose exceeding 15 Gy or severe hepatic artery-portal vein shunting
  • Less than 30% of non-tumorous liver volume remaining outside the treatment area
  • Planned use of immunotherapy regardless of radioembolization response
  • Active cancer within the last two years
  • Prior surgery or procedures involving the bile duct
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, Seoul, South Korea, 03080

Actively Recruiting

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Research Team

J

Jin Woo Choi, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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