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NCT Number: NCT06166576

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center, Ilsan, Gyeonggi-do, South Korea

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About this study

Patients diagnosed with unilobar hepatocellular carcinoma and localized portal vein tumor thrombosis (Vp1-Vp3), who also exhibit good liver function, will undergo ablative radioembolization with a dose exceeding 205 Gy to the tumor using TheraSphere glass microspheres. These patients will be monitored over a two-year period to evaluate their clinical course, treatment outcomes, and safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
  • ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
  • ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)
  • Creatinine ≤ 2.0 mg/dL
  • Patients with a life expectancy of more than 3 months
  • Patients who have fully understood the clinical trial and given written consent
  • Female patients of childbearing age confirmed not to be pregnant

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Overall survival

    Time frame: 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

  1. Objective response rate according to mRECIST

    Time frame: 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)

  2. Duration of response according to mRECIST

    Time frame: 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)

  3. 2-year restricted mean duration of response according to localized mRECIST and mRECIST

    Time frame: 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

  4. Complete response rate according to localized mRECIST and mRECIST

    Time frame: 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)

  5. Duration of complete response according to localized mRECIST and mRECIST

    Time frame: 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)

  6. 2-year restricted mean DoCR (RMDoCR) according to localized mRECIST and mRECIST

    Time frame: Time of complete 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

  7. Best response within 2-years according to localized mRECIST and mRECIST

    Time frame: 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)

  8. Time to best response according to localized mRECIST and mRECIST

    Time frame: 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)

  9. Time to progression according to localized mRECIST and mRECIST

    Time frame: 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)

  10. 2-year restricted mean survival time of overall survival

    Time frame: Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or 24 months the initial treatment

  11. Progression-free survival

    Time frame: 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)

  12. Hepatic progression-free survival

    Time frame: 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)

  13. Pathological necrosis rate (%) after curative resection or liver transplantation

    Time frame: 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)

  14. Time to subsequent HCC treatment

    Time frame: 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)

  15. Reason for subsequent HCC treatment

    Time frame: 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)

  16. Rate for conversion to curative resection and liver transplantation

    Time frame: 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)

  17. Adverse event and serious adverse event

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

    Common Terminology Criteria for Adverse Events v5.0

  18. Changes in Child-Pugh class

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

  19. Changes in ALBI (albumin-bilirubin) grade

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

  20. Changes in MELD (Model for end-stage liver disease) score

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

  21. Changes in ECOG (Eastern Cooperative Oncology Group) performance status scale

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

    0 (fully active) to 5 (dead)

  22. Objective response rate according to localized mRECIST

    Time frame: 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)

    The number of patients with partial or complete response as the best local response divided by the total number of participants

  23. Duration of response according to localized mRECIST

    Time frame: 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)

    The time from first documentation of partial or complete response to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer treatment, whichever comes first

Other outcomes

  1. Pre-treatment dosimetry based on 99mTc-MAA SPECT-CT

    Time frame: Baseline

  2. Post-treatment dosimetry based on Y90 PET-CT

    Time frame: Within two days after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Woo Choi, MD, PhD

CONTACT

[email protected]

+82-220722584

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

An Open-label, Prospective, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Ablative Radioembolization Using Yttrium-90 Glass Microspheres in Patients With Locally-advanced Hepatocellular Carcinoma

Acronym: RESOLVE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2023
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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