Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

NCT06178198 | Recruiting Phase 2

• 2 other identifiers: D-2306-208-1446NRF-2023R1A2C1006509
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Radioembolization

Outcome Measures

Primary Outcomes (2)

• Objective response rate according to localized mRECIST

  The number of patients with partial or complete response as the best local 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)

• Duration of response according to localized mRECIST

  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

  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)

Secondary Outcomes (24)

• 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)

Ablative radioembolization for large HCC

EXPERIMENTAL

Yttrium-90 resin microspheres (SIR-Sphere, SIRTEX) will be administered to cover the main tumor, satellite nodules, and margin.

Procedure: Ablative radioembolization using Yttrium-90 resin microspheres

Interventions

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.

Ablative radioembolization for large HCC

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Related Publications (3)

• Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.

  PMID: 33166497 BACKGROUND

• Choi JW, Suh M, Paeng JC, Kim JH, Kim HC. Radiation Major Hepatectomy Using Ablative Dose Yttrium-90 Radioembolization in Patients with Hepatocellular Carcinoma 5 cm or Larger. J Vasc Interv Radiol. 2024 Feb;35(2):203-212. doi: 10.1016/j.jvir.2023.10.011. Epub 2023 Oct 21.

  PMID: 37866475 BACKGROUND

• Levillain H, Bagni O, Deroose CM, Dieudonne A, Gnesin S, Grosser OS, Kappadath SC, Kennedy A, Kokabi N, Liu DM, Madoff DC, Mahvash A, Martinez de la Cuesta A, Ng DCE, Paprottka PM, Pettinato C, Rodriguez-Fraile M, Salem R, Sangro B, Strigari L, Sze DY, de Wit van der Veen BJ, Flamen P. International recommendations for personalised selective internal radiation therapy of primary and metastatic liver diseases with yttrium-90 resin microspheres. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1570-1584. doi: 10.1007/s00259-020-05163-5. Epub 2021 Jan 12.

  PMID: 33433699 BACKGROUND

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

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

Model Details: Open-label, prospective, single-arm, single-center trial

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 20, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)