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NCT Number: NCT06178198

Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

The RESCUE trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of ablative radioembolization using Yttrium-90. This treatment is being investigated as a potential curative approach, as well as a bridging or downstaging strategy for surgery, in patients with large hepatocellular carcinoma (greater than 8 cm) 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

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Jin Woo Choi, MD, PhD

CONTACT

[email protected]

+82-220722584

Jin Woo Choi, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Patients presenting with large hepatocellular carcinoma (greater than 8 cm), whether accompanied by satellite nodules or not, but retaining good liver function, will undergo ablative radioembolization utilizing Yttrium-90 resin microspheres. This approach is designed to deliver an ablative dose to both tumors and the surrounding liver (i.e., margin) with curative intent, while preserving over 30% of the non-tumorous liver volume. The efficacy and safety of this treatment will be evaluated over a period of two years and 90 days, respectively.

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 hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5).
  • Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm.
  • Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI.
  • Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI.
  • Patients with no prior treatment for liver cancer.
  • Child-Pugh class A.
  • ECOG performance status of 1 or less.
  • Patients with no major organ dysfunction according to blood tests performed 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 (transfusion allowed to meet this criterion)
  • Total bilirubin ≤ 3.0 mg/dL
  • Platelet ≥ 50,000/µL
  • INR ≤ 2.0 for patients not taking anticoagulants
  • 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 adequately understood the clinical trial and consented in writing.
  • Non-pregnant women of childbearing potential.

Exclusion criteria

  • Patients who are not suitable for ablative radioembolization as indicated by pre-treatment testing with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
  • Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed dose is administered to the tumor based on the partition method.
  • Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments.
  • 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 scheduled to use immunotherapy irrespective of the response to radioembolization.
  • Patients who have had active cancer within the last two years prior to the clinical trial participation.
  • Patients who have undergone surgery or procedures related to the bile duct.
  • Women who are pregnant or breastfeeding.

Treatment and study plan

Ablative radioembolization using Yttrium-90 resin microspheres

Procedure

Based on 99mTc-MAA mapping, a partition model (multi-compartment MIRD) is employed to plan for a radiation dose of 400 (± 30%) to the tumor. If delivering this dose to the tumor is challenging due to lung dose limitations, the maximum feasible dose is administered to the tumor while maintaining the estimated lung dose below 15 Gy. While treating the entire tumor with a single high-dose radioembolization session is preferred, if necessary due to considerations like estimated lung dose, the treatment can be divided into two sessions, keeping the cumulative lung dose below 25 Gy. For any methods not covered in this discussion, refer to the SIR-Sphere user manual by Sirtex.

Primary outcomes

  1. 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

  2. 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

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. Overall 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)

  11. 2-year restricted mean survival time of overall survival

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

  12. 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. Hepatic progression-free survival (HPFS)

    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. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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

  19. Changes in Child-Pugh class

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

  20. Changes in ALBI (albumin-bilirubin) grade

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

  21. 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

  22. 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)

  23. Changes in health-related quality of life

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

    EORTC QLQ-C30 and HCC18

  24. Changes in regional liver function

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

    99mTc-MAA hepatobiliary scan with SPECT-CT

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, Single-arm, Single-center Clinical Trial to Evaluate the Efficacy and Safety of Yttrium-90 Ablative Radioembolization (Radiation Major Hepatectomy) for Unifocal Large Hepatocellular Carcinoma

Acronym: RESCUE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2023
Registry last updated
Jan 7, 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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