TY - JOUR
T1 - Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC
T2 - the RALLY protocol
AU - Andel, Daan
AU - Lam, Marnix G. E. H.
AU - de Bruijne, Joep
AU - Smits, Maarten L. J.
AU - Braat, Arthur J. A. T.
AU - Moelker, Adriaan
AU - Vegt, Erik
AU - Ruiter, Simeon J. S.
AU - Noordzij, Walter
AU - Grazi, Gianluca
AU - Vallati, Giulio E.
AU - Bennink, Roel J.
AU - van Delden, Otto M.
AU - Kranenburg, Onno W.
AU - Ijzermans, Jan N. M.
AU - Nijkamp, Maarten W.
AU - Erdmann, Joris I.
AU - Sciuto, Rosa
AU - Hagendoorn, Jeroen
AU - Borel Rinkes, Inne H. M.
N1 - Funding Information: The authors thank Ramona Bailey-Gerritsen, Rosalie van den Boogaard, Tjitske Kent-Bosma and Shanta Kalaykhan-Sewradj (clinical research coordinators, University Medical Centre Utrecht) for their contribution to the study design and coordination of the study. Version number: 3.0, date: 13.07.21. Funding Information: This study is funded by Terumo Corporation (IO-057-QS). The funding body had no role in the design of the study nor the writing of this manuscript and will have no role in the collection, analysis and interpretation of the data. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - 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.
AB - 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.
KW - Hepatocellular carcinoma
KW - Ho
KW - Holmium-166
KW - Radiation lobectomy
KW - Radioembolization
KW - Unilobar radioembolization
UR - http://www.scopus.com/inward/record.url?scp=85168361524&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12885-023-11280-9
DO - https://doi.org/10.1186/s12885-023-11280-9
M3 - Article
C2 - 37596578
SN - 1471-2407
VL - 23
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 771
ER -