Streamlined radioembolization for cholangiocarcinoma and liver cancer that has spread
Follows adults given same-day radioembolization for cholangiocarcinoma or metastatic liver cancer.
Plain-language title generated from the registry record
Registry title: Streamlining Radioembolization for CCC and Metastatic Liver Cancer
Key facts
- Where
- Goyang-si and Seoul, South KoreaSee the 4 sites
Where in South Korea
- National Cancer CenterGoyang-si, South KoreaNot yet recruiting
- Samsung Medical CenterSeoul, South KoreaNot yet recruiting
- Seoul National University HospitalSeoul, South KoreaTaking people
- Severance hospitalSeoul, South KoreaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seoul National University Hospital
- Trial code
- NCT07043387
- Record updated
- 18 August 2026
- Original description
TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT/CT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF >20%, and may be used with caution if LSF is 10-20%.Read full original descriptionShow less
Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study
TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT/CT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF >20%, and may be used with caution if LSF is 10-20%.
Findings associated with high LSF include large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels. In contrast, small or medium sized (<7 cm) cholangiocarcinoma or metastatic liver cancers without hepatic vein invasion or dysmorphic vessels show consistently low LSF (<5%). Over 10 years at SNUH, no cases of radiation pneumonitis have been observed in such patients. Therefore, "streamlining TARE" omits pre-procedural nuclear imaging for this group to reduce procedural delays, reserving nuclear imaging for patients who need it most.
SIR-Spheres (SIRTEX) facilitate single-session TARE as they are provided in a bulk vial, unlike TheraSphere which requires advance preparation based on dosimetry.
Protocol Overview :
Procedure: Same-day angiography, cone-beam CT, and TARE using SIR-Spheres.
Dosimetry: Lung shunt fraction is assumed as 5%, estimated lung dose is capped at 10 Gy.
Tumor dose goal: 80~400 Gy (around 250Gy)(single-compartment MIRD), or 300 ~ 1000 Gy (multi-compartment MIRD). minimal tumor dose by partition dosimetry : 100Gy
Software: Simplicit90Y for planning, Y90 PET/CT the next day for post-treatment dosimetry.
Follow-up: 1 year; additional treatments follow institutional guidelines.
This streamlined approach maximizes efficiency while maintaining safety in selected patients.
Inclusion: 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: 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; History of severe allergy of intolerance to contrast agents; 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; biliary stent or bilioenteric anastomosis; Contraindication to angiography or selective visceral catheterization.