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Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

NCT06178198 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-07

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Ablative radioembolization using Yttrium-90 resin microspheres

Based on 99mTc-MAA mapping, a partition model (multi-compartment MIRD) is employed to plan for a radiation dose of 400 (± 30%) to the tumor. If delivering this dose to the tumor is challenging due to lung dose limitations, the maximum feasible dose is administered to the tumor while maintaining the estimated lung dose below 15 Gy. While treating the entire tumor with a single high-dose radioembolization session is preferred, if necessary due to considerations like estimated lung dose, the treatment can be divided into two sessions, keeping the cumulative lung dose below 25 Gy. For any methods not covered in this discussion, refer to the SIR-Sphere user manual by Sirtex.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jin Woo Choi, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06178198 on ClinicalTrials.gov