GlobeNewswire·Apr 23, 2026, 9:01 AM ET

Alpha Tau Successfully Treats First Pancreatic Cancer Patient in Europe with Alpha DaRT® in French Multicenter ACAPELLA Clinical Trial

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Alpha Tau Medical announced the successful treatment of the first patient in the ACAPELLA European multicenter clinical trial for inoperable locally advanced pancreatic ductal adenocarcinoma (LAPC).
The procedure was performed at CHU Grenoble Alpes by Principal Investigator Pr. Gaël Roth, marking the first use of Alpha DaRT for pancreatic cancer in Europe.
ACAPELLA evaluates Alpha DaRT alpha-emitter radiotherapeutics combined with capecitabine for patients who have completed first-line mFOLFIRINOX chemotherapy, a population lacking standard consolidation therapy.
Approximately 30% of the 140,000 Europeans diagnosed with pancreatic cancer annually present with locally advanced, inoperable, non-metastatic disease.
The trial is a key pillar of Alpha Tau's global clinical expansion strategy in Europe, running concurrently with the IMPACT trial in the United States.
Patient enrollment in ACAPELLA targets up to 40 participants with histologically confirmed inoperable LAPC who have stable disease or tumor response after 8 to 12 cycles of mFOLFIRINOX.
The treatment protocol involves direct intratumoral delivery of Alpha DaRT sources under real-time endoscopic ultrasound guidance, followed by two months of oral capecitabine initiated three days post-procedure.
The primary endpoint of the trial is the safety of the combination therapy, measured by the incidence of device-related serious adverse events graded per CTCAE v5.0 criteria.
Secondary endpoints include objective tumor response rate at 2, 4, and 6 months, overall survival, progression-free survival at 12 months, and the rate of conversion to surgical resectability.
The trial will be conducted across multiple centers in France with follow-up extending to 12 months after the Alpha DaRT procedure.
First patient treatment occurred ahead of Digestive Disease Week (DDW) 2026 in Chicago, where Alpha Tau will highlight its pancreatic cancer program.
Alpha DaRT technology utilizes radium-224 impregnated sources to deliver high-energy alpha particles that destroy tumor cells while sparing surrounding healthy tissue.
The study includes an embedded immune biomarker program to evaluate how intrapancreatic alpha-emitter therapy reshapes the tumor immune microenvironment.