Thank you for your interest in the HyperAcute® Pancreas immunotherapy clinical trial.
This trial is designed for individuals who have been diagnosed with pancreatic cancer and have had surgical resection within the past 8 weeks or are scheduled for surgical resection, and show no evidence of disease at the time of treatment initiation.
Pancreatic cancer clinical trials are research studies designed to investigate optional treatments for patients living with cancer of the pancreas. Before a drug can be approved for treatment in the United States, the Food and Drug Administration (FDA) closely monitors trial participants to ensure safety. The FDA then reviews clinical trial data to determine if an experimental treatment will be approved to treat other patients.
Newly introduced drugs for the treatment of pancreatic cancer must pass through three phases of clinical trial testing prior to receiving FDA approval. Phase I of a clinical trial involves a small number of people, and is initiated when a new drug has shown promise in lab tests. If the drug proves safe during this initial phase, it moves on to a Phase II clinical trial – where the drug is given to a larger group of people. Here, the primary goal is to more closely research the treatments effectiveness against cancer cells and to further evaluate its safety.
This HyperAcute Pancreas immunotherapy clinical trial is now a Phase III trial, where an even larger group of people will be monitored. The Phase III trial is currently enrolling up to 722 previously untreated patients with Stage I or II surgically-resected adenocarcinoma of the pancreas who have minimum residual disease. Investigators will randomly assign patients to receive the current standard of care, either Gemcitabine alone or with 5-FU chemoradiation, with or without HyperAcute-Pancreas immunotherapy. Patients will be treated for approximately six months followed with imaging for five years.
Locate enrolling sites for this U.S. based Phase 3 Clinical Trial.