Streamlining Radioembolization for CCC and Metastatic Liver Cancer

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, simpler way to treat metastatic colorectal cancer (mCRC) in the liver using a procedure called radioembolization (TARE). This treatment delivers tiny radioactive beads directly to liver tumors to help shrink them while sparing healthy liver tissue. Normally, before treatment, patients undergo special scans to check if too many beads might travel to the lungs, which can cause lung damage. This trial focuses on patients with smaller tumors (7 cm or less) and no signs of risky blood vessel patterns, who have a very low chance of lung complications. For these patients, the trial aims to skip the usual pre-treatment lung scans to make the process faster and more convenient without compromising safety.

Adults with unresectable metastatic colorectal cancer in the liver, good liver function, and overall good health may be eligible to join. Participants will have the treatment done in one session, including imaging and bead delivery on the same day, followed by a scan the next day to check the treatment’s accuracy. They will be monitored for up to a year after treatment. This streamlined approach hopes to make the procedure quicker and less burdensome for suitable patients, while still maintaining safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult aged 19 and over
• • metastatic liver cancer or cholangiocarcinoma
• • the diameter of the largest tumor ≤ 7cm, tumor number 5 or less
• • FLR volume \> 30% of total non-tumorous liver volume
• • Dysmorphic intratumoral vessel : absent, if present, 3mm or thinner ⑥ Child-Pugh class A
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑧ No major organ dysfunction according to blood test performed within two months of study enrollment A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (If patients is undergoing hemodialysis, no limit of creatinine) ⑨ Patients with a life expectancy of more than 3 months ⑩ For women of childbearing age, a negative serum pregnancy test. ⑪ Patients who have adequately understood the clinical trial and consented in writing
• Exclusion Criteria:
• • hepatic vein invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)
• • Hepatic vein enhancement on arterial phase CT/MRI
• • dysmorphic intratumoral vessel \> 3mm on arterial phase CT/MRI
• • TIPS is present
• • Lobar portal vein enhancement on arterial phase CT/MRI due to AP shunt
• • main portal vein tumor thrombosis
• • Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT
• • biliary stent or bilioenteric anastomosis
• • History of severe allergy of intolerance to contrast agents
• • Contraindication to angiography or selective visceral catheterization