Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in South Korea / NCT06178198
Recruiting Phase 2

Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

NCT06178198 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Phase 2
Started
2023-11-08
Last updated
2026-08-20

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Ablative radioembolization using Yttrium-90 resin microspheres

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adults aged 18 and over. 2. Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5). 3. Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm. 4. Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI. 5. Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI. 6. Patients with no prior treatment for liver cancer. 7. Child-Pugh class A. 8. ECOG performance status of 1 or less. 9. Patients with no major organ dysfunction according to blood tests performed within one month of study enrollment. 1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL 2. Absolute neutrophil count ≥ 1,500 /mm\^3 3. Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion) 4. Total bilirubin ≤ 3.0 mg/dL 5. Platelet ≥ 50,000/µL 6. INR ≤ 2.0 for patients not taking anticoagulants 7. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 8. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 9. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit) 10. Creatinine ≤ 2.0 mg/dL 10. Patients with a life expectancy of more than 3 months. 11. Patients who have adequately understood the clinical trial and consented in writing. 12. Non-pregnant women of childbearing potential. Exclusion Criteria: 1. Patients who are not suitable for ablative radioembolization as indicated by pre-treatment testing with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization. 1. Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed dose is administered to the tumor based on the partition method. 2. Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments. 2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume. 3. Patients scheduled to use immunotherapy irrespective of the response to radioembolization. 4. Patients who have had active cancer within the last two years prior to the clinical trial participation. 5. Patients who have undergone surgery or procedures related to the bile duct. 6. Women who are pregnant or breastfeeding.

Primary outcome measure(s)

  • Objective response rate according to localized mRECIST — Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
    The number of patients with partial or complete response as the best local response divided by the total number of participants
  • Duration of response according to localized mRECIST — Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
    The time from first documentation of partial or complete response to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer treatment, whichever comes first

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Seoul Recruiting

More Seoul National University Hospital trials in South Korea

Lung Cancer Surgery in Sarcopenia Patients With Old Age Active, not recruiting
Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION) Recruiting
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis Recruiting
Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Recruiting
Reduction of Remifentanil-related Complications Starting soon

Other trials for the same condition

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 Recruiting
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis Recruiting
Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Recruiting
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma Active, not recruiting
Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06178198 on ClinicalTrials.gov ↗ ← All trials in South Korea