TerminatedNot Applicable

Streamlining Radioembolization for Intrahepatic Cholangiocarcinoma

Stopped: This study was merged with NCT07043387. Thus, this study was terminated.

South Korea1 participantsStarted 2025-06-22

Plain-language summary

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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ve…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective response rate according to the RECIST criteria

Timeframe: up to 1 year

Trial details

NCT IDNCT07043348

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-17

View on ClinicalTrials.gov More Intrahepatic Cholangiocarcinoma (Icc) trials