NCT07043348Terminated
Streamlining Radioembolization for Intrahepatic Cholangiocarcinoma
Streamlining Radioembolization for Intrahepatic Cholangiocarcinoma (IHCC) ≤ 7 cm : Multicenter Prospective Registry Study
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Reason given: This study was merged with NCT07043387. Thus, this study was terminated.
Brief summary (registry, in English)
Streamlining TARE for Small IHCC TARE delivers radioactive microspheres (20-60 µm) to tumors via abnormal vasculature, while normal liver sinusoids (<15 µm) block their passage. However, microspheres may enter hepatic veins and reach the lungs, risking radiation pneumonitis. To prevent this, pre-procedural angiography and MAA-based nuclear imaging assess the lung shunt fraction (LSF). TARE is contraindicated if LSF >20% and used cautiously if 10-20%. Large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels suggest high LSF. Dysmorphic vessels are rare in IHCC, an adenocarcinoma with typically low vascularity. Based on 10 years of data from Seoul National University Hospital, IHCC <7 cm without vein invasion or dysmorphic vessels consistently shows LSF <5%, with no cases of radiation pneumonitis. Thus, "streamlining TARE"-omitting nuclear imaging-is safely performed in this population to reduce procedural delays. SIR-Spheres (SIRTEX), provided in a mother vial, enable single-session TARE without advance dosimetry, unlike TheraSphere (Boston Scientific), which requires prior preparation. Protocol (n=40): Procedure: Angiography, cone-beam CT, and TARE on the same day. Dosimetry: Lung dose assumed 5%, capped at 10 Gy. Target absorbed dose ~250 Gy (single-compartment MIRD) or ≥300 Gy (boosted TARE, multi-compartment). Software: Simplicit90Y for planning; Y90 PET/CT for post-treatment dosimetry. Follow-up: 1 year; additional treatment as per institutional guidelines. This streamlined protocol increases efficiency while maintaining safety in selected IHCC patients.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 1 (actual)
- First submitted
- 20 Jun 2025
- Start date
- 22 Jun 2025
- Primary completion date
- 17 Jul 2025
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07043348
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have had active cancer within the last two years prior to the study enrollment
Other illness
- 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
Other
- IHCC with 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
- Contraindication to angiography or selective visceral catheterization
Who the study is looking for
- Adult aged 19 and over
- intrahepatic cholangiocarcinoma (IHCC) diagnosed by histology
- Unresectable IHCC: the diameter of the largest tumor ≤ 7cm
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center | Goyang-si | South Korea | Unknown status |
| Severance hospital | Seoul | South Korea | Unknown status |
| Seoul National University Hospital | Seoul | South Korea | Unknown status |
| Samsung Medical Center | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.