Actively Recruiting
Phase 2 Study of Gemcitabine and Nab-Paclitaxel with TheraBionic P1 Device for Treating Metastatic Pancreatic Cancer
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2026-08-10
30
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of nab-paclitaxel, gemcitabine, and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device called TheraBionic P1 for patients with metastatic pancreatic adenocarcinoma. This Phase 2 trial aims to find out if this combined treatment is safe and effective for this advanced cancer. Participants will receive standard chemotherapy with nab-paclitaxel and gemcitabine administered weekly in specific doses through infusions. Alongside chemotherapy, the TheraBionic P1 device delivers low-level radio waves into the body via a spoon-shaped antenna placed in the mouth three times daily for one hour each session. This treatment plan continues as scheduled during the study. Throughout the study, participants will have multiple assessments including imaging scans to measure tumor response and progression. Researchers will monitor progression-free survival at 6 months as the primary outcome, along with other measures such as overall survival, adverse events, and disease control over up to one year. Participants will be closely observed for safety and treatment effects during the study period, which runs until July 2027.
CONDITIONS
Brief Title
Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer
Research Team
A
Anthony F Shields, MD PhD
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