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