Intra-arterial vs. IV Chemotherapy for Pancreatic Cancer

(TIGeR-PaC Trial)

This trial compares two methods of delivering chemotherapy for pancreatic cancer that cannot be surgically removed. One group will receive gemcitabine and nab-paclitaxel through an IV, while the other group will receive gemcitabine directly into the artery near the tumor. The trial aims to determine which method is more effective for advanced pancreatic cancer. Individuals diagnosed with this type of cancer within the last six weeks who have not yet received major treatments may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have had any anti-cancer therapy, including chemotherapy or radiotherapy, within 2 weeks before starting the study treatment. It's best to discuss your current medications with the study team.

Studies have shown that using the RenovoCath device to deliver gemcitabine may offer safety benefits. This method targets the drug directly to the pancreas, potentially reducing side effects elsewhere in the body.

In a previous study, patients handled this targeted delivery well. Some research even suggests it might lower the risk of serious side effects. Additionally, the FDA has already approved gemcitabine for other uses, indicating its general safety for humans.

For intravenous (IV) treatment, gemcitabine is often combined with nab-paclitaxel for pancreatic cancer. Past patients have generally tolerated these drugs well, although they can still cause side effects like tiredness or nausea.

Researchers are excited about the new approaches to delivering chemotherapy for pancreatic cancer because they offer innovative ways to attack the disease. Unlike the standard intravenous (IV) chemotherapy, which is administered through a vein, the investigational intra-arterial (IA) method delivers chemotherapy directly to the pancreas through the arteries. This targeted delivery could mean higher concentrations of the drug reach the tumor, potentially increasing its effectiveness while minimizing side effects elsewhere in the body. The IA approach uses a device called RenovoCath, which allows for precise delivery of gemcitabine, making it a promising alternative to traditional methods.

This trial will compare two treatment approaches for advanced pancreatic cancer. One arm delivers the drug gemcitabine directly into the arteries using a device called RenovoCath. Research has shown this method to be promising, with nearly 60% of patients surviving for 12 months, a significant improvement over past methods. This approach appears to deliver the drug to the tumor more effectively, potentially enhancing its efficacy and resulting in fewer side effects, making it a more comfortable option.