Clinical trial · Observational
Streamlining Radioembolization for CCC and Metastatic Liver Cancer
Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 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
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Colorectal Carcinoma (mCRC) | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
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 localized 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 according to RECIST and localized RECIST
- 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
* 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 catheterizationReferences
Publications (0)
Data not yet available