Sonire Therapeutics Launches First U.S. Clinical Trial of Ultrasound-Guided HIFU for Pancreatic Cancer
核心洞察
Sonire Therapeutics (搜索) has initiated SUNRISE-II, its first U.S. clinical trial evaluating ultrasound-guided High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer (搜索) patients.
The feasibility study at Stanford University will enroll 10 participants to assess safety of the minimally invasive, anesthesia-free thermal ablation treatment approach.
The HIFU system has received FDA Breakthrough Device Designation and represents a potential advancement for pancreatic cancer (搜索), which has a five-year survival rate of only 13 percent.
Sonire Therapeutics (搜索) has launched its first U.S. clinical trial evaluating a novel ultrasound-guided High-Intensity Focused Ultrasound (HIFU) therapy system for treating pancreatic cancer (搜索), marking a significant milestone in the company's expansion into American clinical development.
The SUNRISE-II feasibility trial is now enrolling patients at Stanford University to assess the safety and feasibility of Sonire's proprietary HIFU system in patients with unresectable pancreatic tumors. The study represents the company's entry into U.S. clinical development after prior experience in Japan.
Trial Design and Patient Population
The SUNRISE-II trial (NCT07033689) will enroll a total of 10 participants with unresectable pancreatic ductal adenocarcinoma (搜索). Principal investigator Pejman Ghanouni, MD, PhD, a radiologist who directs Stanford Medicine's Minimally Invasive MR Interventional Center and the Focused Ultrasound Center of Excellence, performed the first patient treatment in March 2026.
The study targets patients with locally advanced pancreatic cancer (搜索) that cannot be surgically removed due to involvement with surrounding blood vessels, even when the disease remains confined to the pancreas and nearby structures. Participants will undergo focused ultrasound treatment before initiating standard first-line chemotherapy (搜索), with the chemotherapy regimen beginning within two weeks after the HIFU procedure.
Follow-up visits are scheduled at one month and three months after treatment initiation to monitor safety and treatment response.
Technology and Treatment Approach
Sonire's HIFU therapy (搜索) system leverages real-time ultrasound guidance to enable precise, minimally invasive tumor ablation through localized thermal energy delivery. The platform allows physicians to monitor treatment in real time while delivering targeted energy to the tumor site, without requiring general anesthesia.
"Treatment options for pancreatic cancer (搜索) remain extremely limited due to the complexity and location of the disease," said Tohru Satoh, President and CEO of Sonire Therapeutics (搜索). "Initiating SUNRISE-II in the United States is a defining milestone for our company. It enables us to begin building clinical evidence in a new market while advancing a treatment approach designed to be less invasive and more accessible for patients."
The approach has the potential to reduce procedural burden on patients and providers while expanding access to treatment in outpatient settings, representing a significant departure from more invasive surgical interventions.
Clinical Context and Regulatory Status
According to the American Cancer Society, pancreatic cancer (搜索)'s five-year survival rate remains approximately 13 percent, significantly lower than many other major cancers. The limited treatment options available for this challenging malignancy underscore the clinical need for innovative therapeutic approaches.
Sonire's HIFU platform has received Breakthrough Device Designation from the U.S. Food and Drug Administration, highlighting the regulatory agency's recognition of the technology's potential to address unmet medical needs in pancreatic cancer (搜索) treatment.
The company previously launched a similar clinical trial in Japan in 2023, and results from that study are being closely monitored to inform the broader development program.
Strategic Implications
The SUNRISE-II trial reflects Sonire's broader strategy to expand into U.S. clinical development and generate high-quality evidence to support future regulatory submissions and global commercialization. By initiating clinical development at leading institutions like Stanford, the company aims to accelerate adoption of this less invasive treatment option for patients with difficult-to-treat tumors.
If safety is confirmed in this feasibility study, the approach could advance to larger clinical trials to further evaluate efficacy and establish the role of HIFU therapy (搜索) in pancreatic cancer (搜索) treatment algorithms.