Streamlining Radioembolization for Intrahepatic Cholangiocarcinoma

NCT07043348 | Terminated

• 1 other identifier: 2505-093-1640
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Outcome Measures

Primary Outcomes (1)

• Objective response rate according to the RECIST criteria

  up to 1 year

Secondary Outcomes (4)

• Overall survival (OS) rates

  From date of radioembolization until the date of death from any cause, assessed up to 60 months

• Progression free survival (PFS) rates

  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

• AE and serious adverse event (SAE) according to CTCAE v5.0

  Time of treatment up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first

• The presence or absence of radiation pneumonitis diagnosed by chest simple X-ray or CT

  Time of treatment up to 180 days after the initial treatment or subsequent anticancer treatment, whichever comes first

Study Arms (1)

streamlining group

radioembolization is performed without MAA scan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with intrahepatic cholangiocarcinoma who are scheduled for radioembolization

You may qualify if:

• 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

You may not qualify if:

• 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 catheterization

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

National Cancer Center

Goyang-si, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: June 22, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)