Targeted intra-arterial gemcitabine vs. continuation of IV gemcitabine plus nab-paclitaxel following induction with sequential IV gemcitabine plus nab-paclitaxel and radiotherapy for unresectable locally advanced pancreatic cancer (TIGeR-PaC): A randomized phase 3 multicenter study.

• DOI: 10.1200/jco.2023.41.4_suppl.tps773
• Publication Date: 2023-01-24T21:05:07Z
• Authors: Michael J. Pishvaian; Amer H. Zureikat; Charles D. Lopez; Kenneth Meredith; Emmanuel E. Zervos; Hassan Hatoum; Ki Y. Chung; Daniel James Berg; Antonio Ucar; Ripal T Gandhi; Reza Nazemzadeh; Nainesh Parikh; Paula M. Novelli; Brian Kouri; Christopher Laing; Brian A. Boone; Thor Johnson; Susan Elaine Bates; Ramtin Agah; Karyn A. Goodman
• Keywords: Clinical endpoint; Concomitant; Induction chemotherapy

TPS773 Background: Prognosis for locally advanced pancreatic cancer (LAPC) remains dismal even with advances in therapy. Beyond systemic therapies, local disease control is important these patients. Local double balloon mediated delivery of intra-arterial gemcitabine (IAG) was demonstrated to be safe this patient population a prior study 1 . TIGeR-PaC an ongoing Phase-3 clinical trial comparing the efficacy approach compared standard care IV gemcitabine/nab-paclitaxel (GN) patients LAPC. Methods: The designed induction phase upfront therapy IAG. Patients LAPC diagnosed within 6 weeks and ECOG 0-1, receive 3 cycles GN cycle radiation. form radiation either IMRT, 50 Gy 25 fractions, concomitant capecitabine or SBRT, 33 5 fractions (per site preference). Following induction, non-progressive were randomized IAG (8 treatments every two 16 weeks) continuing 4 GN. After therapy, went on continue (GN capecitabine, per investigator’s preference) until progression then followed survival only. primary endpoint overall survival, has 80% power detect hazard ratio 0.6 between arms. As September st , 2022, 189 have been enrolled trial. In its initial design expected 35% drop out rate during phase; however, years into actual observed dropout 53%. (22%), key element AE/SAE IMRT/capecitabine (17%) vs. only 6% SBRT. To increase accrual patients, protocol statistical plan modified restrict mode SBRT starting December 2021. Since modification protocol, decreased 38%. abstract, 43 following SAE active treatment not different 2 arms (20% each arm), most common GI side effects both pre-planned interim analysis after 26 events, 23 events at writing we expect our first later year. 1. Rosemurgy AS, e al: J Pancreat Cancer. 2017;3(1):58-65. doi:10.1089/pancan.2017.0011. Clinical information: NCT03257033