Gemcitabine for Pancreatic Cancer

(PRISM-TAMP Trial)

This trial explores a new method to deliver gemcitabine, a chemotherapy drug, directly to pancreatic tumors. The goal is to determine if this method is safe and effective for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC), a challenging cancer to treat. Participants will receive standard chemotherapy and radiation, followed by gemcitabine delivered directly to the tumor through a special catheter. The trial seeks individuals with PDAC who have not undergone previous treatment and have tumors potentially removable by surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that gemcitabine, a chemotherapy drug, is generally well-tolerated by patients with pancreatic cancer. In one study, patients with advanced pancreatic cancer found gemcitabine-based treatments effective and safe, with manageable side effects. Another study demonstrated that combining gemcitabine with other drugs like capecitabine extended patients' lives without increasing side effects.

Researchers are excited about the treatment involving gemcitabine for pancreatic cancer because it features a novel delivery method known as trans-arterial microperfusion (TAMP). Unlike standard treatments, which typically involve systemic chemotherapy, TAMP allows for gemcitabine to be delivered directly to the tumor site using the RenovoCath® catheter system. This targeted approach potentially increases the concentration of the drug at the cancer site while minimizing exposure to the rest of the body, which could lead to enhanced effectiveness and reduced side effects. Additionally, combining this with existing treatments like modified FOLFIRINOX and stereotactic body radiation therapy (SBRT) could improve outcomes for patients with borderline resectable pancreatic ductal adenocarcinoma.

Studies have shown that gemcitabine effectively treats pancreatic cancer. When used after FOLFIRINOX, gemcitabine has benefited some patients. Research indicates that combining gemcitabine with other drugs can extend patient survival, with some studies showing a 20% lower risk of death. In this trial, participants will receive gemcitabine directly to the tumor using the RenovoCath® catheter system, potentially enhancing its effectiveness. This new delivery method has shown early promise in improving existing treatments.⁶⁷⁸⁹¹⁰