Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria

NCT06773845 | Recruiting Phase 2

• 1 other identifier: 2412-135-1601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.

Conditions

Hepatocellular Carcinoma (HCC); Radioembolization

Keywords

Hepatocellular carcinoma; Radioembolization; SIRT

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) according to the mRECIST

  The number of patients with partial or complete response accroding to the mRECIST as the best response, divided by the total number of participants (%)

  Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

Secondary Outcomes (15)

• ORR according to the RECIST 1.1

  Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

• ORR according to localized mRECIST and RECIST 1.1

  Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

• Duration of response according to mRECIST, localized mRECIST, and RECIST 1.1

  Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

• Overall survival rate

  Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

• Progression-free survival rates according to mRECIST, localized mRECIST, and RECIST 1.1

  Time of treatment up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

Study Arms (1)

Radioembolization

EXPERIMENTAL

Ablative radioembolization using Yttrium-90 glass microspheres

Device: TheraSphere

Interventions

TheraSphere DEVICE

The multicompartment MIRD model (a.k.a. partition model) based on diagnostic CT/MRI and 99mTc-MAA SPECT-CT will be used to plan a targeted dose of 700 Gy (± 50%) to the tumor. Given the high tumor burden, a scheduled second radioembolization within 120 days from the initial treatment will be permitted at the discretion of the operators provided the cumulative lung dose remains below 50 Gy. A scheduled second radioembolization may be considered when the largest tumor diameter exceeds 8 cm, or the estimated lung dose reaches 30 Gy while the tumor absorbed dose remains below the target dose of 700 Gy. The radioactive microsphere delivery device used will be glass-based (TheraSphere; Boston Scientific, MA, USA), in which Y90 is an integral constituent of the biocompatible glass matrix. Dosimetry planning will be made by personalized dosimetry software (Simplicit90y; Boston Scientific).

Also known as: Y90 glass microsphere

Radioembolization

Eligibility Criteria

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

You may qualify if:

• Adult aged 19 and over
• HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease
• Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \> 7
• Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments
• No current or previous HCC in the untreated liver (i.e., future liver remnant \[FLR\])
• FLR volume \> 30% of total non-tumorous liver volume
• Child-Pugh class A
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• No major organ dysfunction according to blood test performed within two months of study enrollment:
• Leukocytes ≥ 2,000/µL and ≤ 15,000/µL
• Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion)
• Total bilirubin ≤ 2.0 mg/dL
• Platelet ≥ 40,000/µL
• International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants
• Aspartate transaminase (AST) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)

You may not qualify if:

• HCC with vascular invasion and/or bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)
• HCC with extrahepatic spread on chest CT and abdominal CT or MRI
• Multinodular disseminated HCC: largest tumor size \< 6 cm, or number of tumors \> 10
• Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA):
• Cases where the estimated lung dose exceeds 30 Gy when 350 Gy of tumor absorbed dose is administered to the tumor based on the multicompartment Medical Internal Radiation Dose (MIRD) model
• Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments
• Cases where the operator determines that there is substantial adhesion with the surrounding organs such as the bowel, making ablative radioembolization infeasible
• 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
• Boston Scientific Corporation: collaborator

Study Sites (4)

National Cancer Center

Ilsan, Gyeonggi-do, 10408, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Jin Woo Choi, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Hyun Hee Lee

CONTACT

+82 220724177; redlion55@snu.ac.kr

Mina Lee

CONTACT

mina.lee@bsci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)