The #HOPE4LIVER Single-arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors
Timothy J. Ziemlewicz, Jeff Critchfield, Mishal Mendiratta‐Lala, Philipp Wiggermann, Maciej Pech, Xavier Serres, Meghan Lubner, Tze Min Wah, Peter Littler, Clifford Davis, Govindarajan Narayanan, Sarah B. White, Osman Ahmed, Zachary Collins, Neehar D. Parikh, Mathis Planert, Maximilian Thormann, Guido Torzilli, Luigi Solbiati, Clifford S. Cho
Abstract
OBJECTIVE: To evaluate the 1-year clinical outcomes of patients enrolled in the #HOPE4LIVER trial of hepatic histotripsy. BACKGROUND: Histotripsy is a novel noninvasive, non-thermal-focused ultrasound therapy that liquefies tissue at the focal point of the transducer. Following diagnostic ultrasound targeting, an automated treatment is performed through 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 through a core laboratory with a primary assessment at each time point and a post hoc assessment performed following the 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 through 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 6 serious adverse device-related effects within 30 days of treatment. Only one nonserious adverse device-related effect was observed after 30 days of treatment. Overall survival at 1-year was 73.3% for patients with hepatocellular carcinoma and 48.6% for patients with metastatic disease. CONCLUSIONS: Histotripsy results in local control of liver tumors at 1 year, which 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.