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. 2025 Apr 9.
doi: 10.1097/SLA.0000000000006720. Online ahead of print.

The #HOPE4LIVER single-arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors: 1-year Update of Clinical Outcomes

Timothy J Ziemlewicz  1 , Jeffrey J Critchfield  2 , Mishal Mendiratta-Lala  3 , Philipp Wiggermann  4 , Maciej Pech  5 , Xavier Serres-Créixams  6 , Meghan Lubner  7 , Tze Min Wah  8 , Peter Littler  9 , Clifford R Davis  10 , Govindarajan Narayanan  11 , Sarah B White  12 , Osman Ahmed  13 , Zach S Collins  14 , Neehar D Parikh  15 , Mathis Planert  4 , Maximilian Thormann  5 , Guido Torzilli  16 , Luigi A Solbiati  16 , Clifford S Cho  17   18
Affiliations

The #HOPE4LIVER single-arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors: 1-year Update of Clinical Outcomes

Timothy J Ziemlewicz et al. Ann Surg. .

Abstract

Objective: To evaluate the 1-year clinical outcomes of patients enrolled in the #HOPE4LIVER trial of hepatic histotripsy.

Summary background data: Histotripsy is a novel non-invasive, non-thermal focused ultrasound therapy that liquefies tissue at the focal point of the transducer. Following diagnostic ultrasound targeting, an automated treatment is performed via a robotic arm to treat a user-defined volume of tissue.

Methods: Forty-seven patients were enrolled at 14 sites in the United States and Europe. Included patients were ineligible for or had opted out of standard therapies. Tumor control was evaluated via a core laboratory with a primary assessment at each time point and a post hoc assessment performed following completion of each time point to allow for a learning curve of interpreting imaging findings of this novel therapy. Overall survival and freedom from local tumor progression were evaluated via the Kaplan-Meier method.

Results: Nineteen patients with hepatocellular carcinoma and 28 with metastatic disease were enrolled, of whom 89.5% (17/19) and 96.4% (27/28) had multifocal hepatic tumors at the time of treatment. Fifty-two tumors were treated. The 1-year local control rate was 63.4% using the primary assessment method and 90% using the post hoc method. There were six serious adverse device-related effects within 30 days of treatment. Only one non-serious adverse device-related effect was observed after 30 days of treatment. Overall survival at 1-year was 73.3% for patients with HCC and 48.6% for patients with metastatic disease.

Conclusions: Histotripsy results in local control of liver tumors at 1-year that is consistent with current locoregional therapies. The safety profile is favorable, and survival at 1 year is comparable with other therapies for similar disease stages.

Keywords: ablation; hepatic metastasis; hepatocellular carcinoma; histotripsy.

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Conflict of interest statement

Conflicts of Interest and Source of Funding: HistoSonics, Inc. funded the trial and provided the HistoSonics System for use at trial sites. Conflicts of Interest: T.J.Z. Grants, HistoSonics, Ethicon, National Cancer Institute of National Institutes of Health (RO1CA262474); consulting fees from Elephas and Histosonics; Participation in a Data Safety Monitoring Board or Advisory Board from Elephas; stock or stock options from HistoSonics, equipment provided to institution from HistoSonics; M.M.L. Support for attending meetings from HistoSonics; ACR and SAR LI-RADS Treatment Response Working Group chair. T.M.W. Grants from Boston Scientific, Angiodynamics, HistoSonics, Johnson and Johnson; consulting fees from Angiodynamics; payment for lectures from Boston Scientific, Angiodynamics, Johnson and Johnson; participation in a Data Safety Monitoring Board or Advisory Board from Angiodynamics, Johnson and Johnson; leadership or fiduciary roles from Faculty Board Royal College of Radiologists, British Society of Interventional Radiology, NIHR, NICE. G.N. Consulting fees from Angiodynamics, Boston Scientific, Varian Interventional Solutions, Stryker, Philips; scientific advisory board for Quantum Surgical and Beta Glue. S.B.W. Consulting fees from Guerbet, Cook Medical, AstraZeneca; payment for lectures from Penumbra; participation on a Data Safety Monitoring Board or Advisory Board from AstraZeneca, Merck, Trisalus, Esai; Member of the SIO board of directors; deputy editor for Radiology. O.A. Grants from Canon Medical; consulting fees from Boston Scientific, Angiodynamics, Johnson and Johnson, Asahi Medical, Argon Medical, Bard; payment for lectures from Penumbra; chief medical officer and equity owner of Flow Medical. N.D.P. Grants or contracts from Exelixis, Genentech, Bayer, TARGET, National Institutes of Health; consulting fees from AstraZeneca, Genentech, Esai, Gilead. C.S.C. Consulting fees for participation as a co-principal investigator for HistoSonics; patent holder for use of histotripsy to generate immunogenic tumor vaccines. All other authors report no relevant conflicts of interest.

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