Streamlined radioembolization for cholangiocarcinoma and metastatic liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational protocol that selects patients judged to have low risk of lung shunting based on tumor size, lesion number, absence of hepatic vein invasion or dysmorphic intratumoral vessels, good liver function (Child-Pugh A), and ECOG performance 0–1. Standard transarterial radioembolization (TARE) normally requires angiography plus a macroaggregated albumin (MAA) nuclear scan to measure lung shunt fraction (LSF); this program documents outcomes when the nuclear scan is omitted for low-risk patients. The rationale is that small or medium tumors (<7 cm) without specific high-risk features consistently show very low LSF (<5%) in prior institutional experience, so omitting the scan could reduce delays and resource use. Patients are enrolled and managed at participating Korean tertiary centers with follow-up to capture safety outcomes such as radiation pneumonitis and liver toxicity.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting
• National Cancer Center
  Goyang-si, South Korea Not yet recruiting
• Samsung Medical Center
  Seoul, South Korea Not yet recruiting
• Severance hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: Hyo-Cheol Kim, MD
• Email: radioembolization@snu.ac.kr
• Phone: 82-10-5136-5205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.