Streamlining Radioembolization for CCC and Metastatic Liver Cancer

NCT07043387 | Recruiting

• 1 other identifier: 2505-094-1640
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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

Metastatic Colorectal Carcinoma (mCRC); Metastatic Liver Cancer; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate according to the localized 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 according to RECIST and localized RECIST

  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 frame: 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 metastatic liver cancer or cholangiocarcinoma who are scheduled for radioembolization

You may qualify if:

• 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

You may not qualify if:

• 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 catheterization

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

National Cancer Center

Goyang-si, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Hyo-Cheol Kim, MD

CONTACT

82-10-5136-5205; radioembolization@snu.ac.kr

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 (Estimated): December 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)