Trans-intra-arterial gemcitabine versus continuation of IV gemcitabine and nab-paclitaxel following radiotherapy for locally advanced pancreatic cancer (TIGeR-PaC).

TPS529Background: Treatment of locally advanced pancreatic cancer (LAPC) remains a challenge, and novel therapy options for local treatment of disease beyond systemic therapy are needed. Recently published data of intra-arterial delivery of gemcitabine (IAG) for local disease control has shown this approach to be safe (J. Pancreatic Cancer 3(1) 58:65). Furthermore, in patients who have received prior radiation for LAPC, there seems to be an effect on the local microvasculature that enhances the clinical efficacy of IAG. TIGeR-PaC is a randomized Phase 3 trial designed to test if the combination of induction systemic chemotherapy plus radiation followed by IAG is superior to systemic chemotherapy plus radiation alone (NCT03257033). Methods: All subjects with biopsy proven, and imaging-confirmed LAPC (by the NCCN guidelines) will receive induction therapy with IV gemcitabine plus nab-paclitaxel, for approximately four months, during which time a course of radiation therapy will also be incorporated. Subject...