- The data from an initial clinical trial in Korea were critical for establishing safety, preliminary efficacy, and the protocol parameters for a larger study.
- Jae Young Lee, MD, PhD, used the ultrasound-guided Alpinion focused ultrasound device plus standard-of-care chemotherapy to decrease tumor size in patients with pancreatic cancer.
- A phase II clinical trial is now underway in Korea and nearing its enrollment goal.
Early, proof-of-concept safety data and the protocol parameters from a pancreatic cancer focused ultrasound plus chemotherapy clinical trial have now been published. This small, 9-participant clinical trial, which completed enrollment in 2019, was critical for establishing safety, preliminary efficacy, and the protocol parameters for the phase II clinical trial that is now underway. All participants were pathologically diagnosed with unresectable pancreatic cancer.
Jae Young Lee, MD, PhD, professor of Radiology and president at Seoul National University Medical Research Center in Korea, is the principal investigator for both (phase I and II) studies. He and his team are using the ultrasound-guided Alpinion focused ultrasound device and standard-of-care chemotherapy regimens to address pancreatic cancer that is unresectable (which is the case in about 80% of patients with pancreatic cancer).
“Pancreatic cancer typically presents with a dense fibrous stroma and low vascularity, which limits drug delivery and efficacy,” said Dr. Lee in the publication. “Therefore, there is an urgent need to develop new treatment options to enhance drug delivery.” Dr. Lee hypothesizes that focused ultrasound can weaken the tumor’s dense stroma to allow chemotherapy to penetrate the cancer cells.
As published in European Radiology, the nine participants in the phase I study were assigned to one of three predefined treatment intensity groups (low, intermediate, or high) for six combined treatments of focused ultrasound plus nab-paclitaxel plus gemcitabine chemotherapy. Although it was primarily a safety study, after treatment, the team also measured changes in tumor size, tumor response, tumor marker levels, patient-reported outcomes, and survival.
The treatments were safe, and participants experienced no adverse effects. Tumor size decreased more than 15% in seven of the nine participants at both the immediate and 3-month follow-up computed tomography scans. Tumor marker levels decreased in all participants. The intermediate intensity treatment was the most effective, with this group showing the largest decreases in tumor size (more than 30%) and tumor markers plus a significant improvement in survival (p < 0.05).
“A key point of the proof-of-concept study is that the Seoul National team showed that they were able to access the patients’ tumors and treat them without complications,” said Tim Meakem, MD, the Foundation’s Chief Medical Officer. “This was not a small issue to solve, because accessing the pancreas with focused ultrasound has been challenging. Some efforts to treat similar patients using MRI guidance have been difficult, simply due to the size and access limitations of the MRI. Dr. Lee used ultrasound guidance for this procedure, which avoided these issues. The safety and initial efficacy of this project were well received by his colleagues, and almost all of the participants for the phase II study have already been enrolled.”
The phase II, 60-participant study is being funded by the Focused Ultrasound Foundation. For phase II, the team is using a FOLFIRINOX regimen of chemotherapy. Dr. Lee presented interim phase II results at the 8th International Symposium on Focused Ultrasound. See the Video >
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