A Potential New Option for Targeted Treatment of Pancreatic Cancer is on the Horizon
Systemic (IV gemcitabine and nab-paclitaxel) chemotherapy is currently
the standard of care for pancreatic cancer treatment. However, it’s known to cause debilitating side effects for patients diagnosed with this disease. Unlike other tumors with extensive blood supply, pancreatic tumors have poor blood supply so systemic chemotherapy may not reach the tumor. Thus, the standard of care may be less effective in treating this type of cancer because the blood vessels are critical for transporting systemic administration of chemotherapy to the tumor.
The Phase III TIGeR-PaC clinical trial is an ongoing randomized multi-center study using RenovoRx’s innovative therapy platform, TAMPä (Trans-Arterial Micro-Perfusion), to evaluate RenovoRx’s first product candidate, RenovoGemä. The study is evaluating trans-arterial delivery, a form of intra-arterial administration, of an FDA- approved chemotherapy, gemcitabine, to treat LAPC following stereotactic body radiation therapy (SBRT). The study is comparing treatment of gemcitabine with TAMP versus systemic IV administration of gemcitabine and nab-paclitaxel.
The first of two interim analyses was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month overall survival (OS) benefit and secondary endpoints including reduced side effects versus standard of care.
The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. Final analysis will be conducted after 86 protocol-specified events (deaths) have occurred in the SBRT population with two interim analyses. The analysis of the first interim analysis at 30%, or 26, of the specified events, was completed March 2023, and the second will occur at 60%, or 52, of the specified events. The 52nd event is estimated to occur in late-2024.
TIGeR-PaC is currently enrolling locally advanced, unresectable LAPC patients at multiple clinical centers across the U.S. Find a clinical site.