The first participant has been enrolled in SONIRE Therapeutics’ multicenter, randomized phase 2 clinical trial for the treatment of unresectable pancreatic cancer in Japan. Ninety participants will be randomly selected to receive either high-intensity focused ultrasound (HIFU) plus chemotherapy or chemotherapy alone.
“The chemotherapy is used as standard therapy, Nal-IRI/FL, mFOLFIRINOX, or Gem/nab-PTX, at the physician’s choice,” explained Tohru Satoh, the company’s CEO. “Because the primary endpoint of this study is overall survival, we will confirm the effect of prolonged survival by the addition of HIFU treatment.”
Researchers are using the company’s next-generation HIFU therapy system, which was was developed based on a device used in a clinical study for pancreatic cancer in Japan in 2017.
At the 2022 meeting of the Taiwan Association of Interventional and Therapeutic Ultrasound (TAITU), a SONIRE representative presented on a method to remove background noise to enhance imaging while treating pancreatic cancer.