Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis

NCT06166576 | Recruiting Phase 2 DMC

• 1 other identifier: D-2306-207-1446
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis (Vp1-Vp3) and who maintain good liver function.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Radioembolization; Portal vein tumor thrombosis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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)

Secondary Outcomes (23)

• Objective response rate according to mRECIST

  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

  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)

• 2-year restricted mean duration of response according to localized mRECIST and mRECIST

  Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or 24 months after the initial treatment

• Complete response rate according to localized mRECIST and mRECIST

  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 complete response according to localized mRECIST and mRECIST

  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)

Other Outcomes (2)

• Pre-treatment dosimetry based on 99mTc-MAA SPECT-CT

  Baseline

• Post-treatment dosimetry based on Y90 PET-CT

  Within two days after the procedure

Study Arms (1)

Radioembolization

EXPERIMENTAL

Hepatocellular carcinoma with localized portal vein tumor thrombosis (Vp1-Vp3) will be treated by ablative radioembolization using TheraSphere (Boston Scientific) glass microspheres

Procedure: Ablative radioembolization

Interventions

Ablative radioembolization PROCEDURE

The interventional radiologist utilizes a pre-test with 99mTc-MAA SPECT-CT and cone-beam CT for procedural planning. For tumors confined to a single segment, the treatment area is planned to receive a radiation dose of over 400 Gy using the single-compartment MIRD technique. For tumors extending beyond a single segment, the multi-compartment MIRD technique is used to plan a radiation dose of 700 Gy (± 20%) to the tumor. The upper limit for the estimated lung dose is set at 25 Gy, and the upper limit for the perfused non-tumoral liver dose is 250 Gy. In cases where tumors extending beyond a single segment cannot receive the planned dose of 700 Gy (± 20%) due to limits on lung or normal liver dose, the plan is adjusted to deliver the maximum dose to the tumor within the permissible range for lung and normal liver doses. Radioembolization is typically performed in a single session, and any methods not mentioned here should follow the instructions for use of TheraSphere.

Radioembolization

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 and over
• Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
• Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
• Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
• Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
• Patients with no prior treatment for liver cancer
• Child-Pugh class A
• Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
• Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment
• Leukocytes ≥ 2,500/µL and ≤ 12,000/µL
• Absolute neutrophil count ≥ 1,500/mm\^3
• Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)
• Total bilirubin ≤ 3.0 mg/dL
• Platelets ≥ 50,000/µL
• For patients not on anticoagulants, INR ≤ 2.0

You may not qualify if:

• Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
• Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy.
• Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.
• Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
• Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
• Patients scheduled to use immunotherapy regardless of the response to radioembolization.
• Patients who had active cancer within two years prior to joining the clinical trial.
• Patients who have undergone surgery or procedures related to the bile duct.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

National Cancer Center

Ilsan, Gyeonggi-do, 10408, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (1)

• Choi JW, Kim GM, Hyun D, Jang MJ, Kim HC. Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma with Localized Portal Vein Tumor Thrombosis (RESOLVE): Protocol for an Open-label, Multi-center, Single-arm Trial. Cardiovasc Intervent Radiol. 2025 Mar;48(3):398-404. doi: 10.1007/s00270-024-03935-2. Epub 2025 Feb 13.

  PMID: 39948248 DERIVED

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Woo Choi, MD, PhD

CONTACT

+82-220722584; jwchoi.med@snu.ac.kr

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: Associate Professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 12, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)