Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

Last updated: January 5, 2025
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Digestive System Neoplasms

Cancer

Treatment

Ablative radioembolization using Yttrium-90 resin microspheres

Clinical Study ID

NCT06178198
D-2306-208-1446
NRF-2023R1A2C1006509
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Adults aged 18 and over.

  2. Patients diagnosed with hepatocellular carcinoma histologically and/orradiologically (LI-RADS 4 or 5).

  3. Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, andthe largest tumor diameter exceeding 8 cm.

  4. Patients without vascular invasion and bile duct invasion in dynamiccontrast-enhanced CT or MRI.

  5. Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominalCT 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 withinone month of study enrollment.

  10. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL

  11. Absolute neutrophil count ≥ 1,500 /mm^3

  12. Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion)

  13. Total bilirubin ≤ 3.0 mg/dL

  14. Platelet ≥ 50,000/µL

  15. INR ≤ 2.0 for patients not taking anticoagulants

  16. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)

  17. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)

  18. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)

  19. Creatinine ≤ 2.0 mg/dL

  20. Patients with a life expectancy of more than 3 months.

  21. Patients who have adequately understood the clinical trial and consented in writing.

  22. Non-pregnant women of childbearing potential.

Exclusion

Exclusion Criteria:

  1. Patients who are not suitable for ablative radioembolization as indicated bypre-treatment testing with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.

  2. Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed doseis administered to the tumor based on the partition method.

  3. Cases with severe hepatic artery-portal vein shunting that might lead toirradiation of the non-tumorous liver segments.

  4. Patients whose volume of non-tumorous liver not included in the treatment area isless than 30% of the total non-tumorous liver volume.

  5. Patients scheduled to use immunotherapy irrespective of the response toradioembolization.

  6. Patients who have had active cancer within the last two years prior to the clinicaltrial participation.

  7. Patients who have undergone surgery or procedures related to the bile duct.

  8. Women who are pregnant or breastfeeding.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Ablative radioembolization using Yttrium-90 resin microspheres
Phase: 2
Study Start date:
November 08, 2023
Estimated Completion Date:
November 30, 2026

Study Description

Patients presenting with large hepatocellular carcinoma (greater than 8 cm), whether accompanied by satellite nodules or not, but retaining good liver function, will undergo ablative radioembolization utilizing Yttrium-90 resin microspheres. This approach is designed to deliver an ablative dose to both tumors and the surrounding liver (i.e., margin) with curative intent, while preserving over 30% of the non-tumorous liver volume. The efficacy and safety of this treatment will be evaluated over a period of two years and 90 days, respectively.

Connect with a study center

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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