Clinical trial · Observational
Streamlining Radioembolization for Intrahepatic Cholangiocarcinoma
Streamlining Radioembolization for Intrahepatic Cholangiocarcinoma (IHCC) ≤ 7 cm : Multicenter Prospective Registry Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was merged with NCT07043387. Thus, this study was terminated.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma (Icc) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- streamlining group
- description
- radioembolization is performed without MAA scan
Primary outcomes (1)
- measure
- Objective response rate according to the RECIST criteria
- timeFrame
- up to 1 year
Secondary outcomes (4)
- measure
- Overall survival (OS) rates
- timeFrame
- From date of radioembolization until the date of death from any cause, assessed up to 60 months
- measure
- Progression free survival (PFS) rates
- timeFrame
- From date of radioembolization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
* Patients who have had active cancer within the last two years prior to the study enrollment
* History of severe allergy of intolerance to contrast agents
* Contraindication to angiography or selective visceral catheterizationReferences
Publications (0)
Data not yet available