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BMC Cancer
Published in: BMC Cancer 1/2023

Open Access 01-12-2023 | Hepatocellular Carcinoma | Study protocol

Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol

Authors: Daan Andel, Marnix G. E. H. Lam, Joep de Bruijne, Maarten L. J. Smits, Arthur J. A. T. Braat, Adriaan Moelker, Erik Vegt, Simeon J. S. Ruiter, Walter Noordzij, Gianluca Grazi, Giulio E. Vallati, Roel J. Bennink, Otto M. van Delden, Onno W. Kranenburg, Jan N. M. Ijzermans, Maarten W. Nijkamp, Joris I. Erdmann, Rosa Sciuto, Jeroen Hagendoorn, Inne H. M. Borel Rinkes

Published in: BMC Cancer | Issue 1/2023

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Abstract

Background

High dose unilobar radioembolization (also termed ‘radiation lobectomy’)—the transarterial unilobar infusion of radioactive microspheres as a means of controlling tumour growth while concomitantly inducing future liver remnant hypertrophy—has recently gained interest as induction strategy for surgical resection. Prospective studies on the safety and efficacy of the unilobar radioembolization-surgery treatment algorithm are lacking. The RALLY study aims to assess the safety and toxicity profile of holmium-166 unilobar radioembolization in patients with hepatocellular carcinoma ineligible for surgery due to insufficiency of the future liver remnant.

Methods

The RALLY study is a multicenter, interventional, non-randomized, open-label, non-comparative safety study. Patients with hepatocellular carcinoma who are considered ineligible for surgery due to insufficiency of the future liver remnant (< 2.7%/min/m2 on hepatobiliary iminodiacetic acid scan will be included. A classical 3 + 3 dose escalation model will be used, enrolling three to six patients in each cohort. The primary objective is to determine the maximum tolerated treated non-tumourous liver-absorbed dose (cohorts of 50, 60, 70 and 80 Gy). Secondary objectives are to evaluate dose–response relationships, to establish the safety and feasibility of surgical resection following unilobar radioembolization, to assess quality of life, and to generate a biobank.

Discussion

This will be the first clinical study to assess the unilobar radioembolization-surgery treatment algorithm and may serve as a stepping stone towards its implementation in routine clinical practice.

Trial registration

Netherlands Trial Register NL8902, registered on 2020–09-15.
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Metadata
Title
Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol
Authors
Daan Andel
Marnix G. E. H. Lam
Joep de Bruijne
Maarten L. J. Smits
Arthur J. A. T. Braat
Adriaan Moelker
Erik Vegt
Simeon J. S. Ruiter
Walter Noordzij
Gianluca Grazi
Giulio E. Vallati
Roel J. Bennink
Otto M. van Delden
Onno W. Kranenburg
Jan N. M. Ijzermans
Maarten W. Nijkamp
Joris I. Erdmann
Rosa Sciuto
Jeroen Hagendoorn
Inne H. M. Borel Rinkes
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2023
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-023-11280-9

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