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Abstract This is a phase II clinical trial was carried out on 50 patients with previously untreated locally advanced, surgically unresectable pancreatic adenocarcinoma presented to Clinical Oncology and Nuclear Medicine Department, Menoufia University. The aim of the study is to evaluate the feasibility of surgery and response rate of neoadjuvant modified FOLFIRINOXlosartan followed by chemoradiotherapy for locally advanced pancreatic cancer. Most of the studied patients had grade II tumors (78%). (76%) of patients had tumor location at head and body, while (24%) had at the tail. Tumor size ranged between 29.0 – 59.0 mm with a mean ± SD of 44.34 ± 7.41 mm and the median size was 43mm. CA 19.9 ranged between (23.0 – 10000 with a mean ± SD of 642.0 ± 1653.0) and the median was 87.0 (43.0 – 654.0). CEA ranged between (1.0 – 98.0(with a mean ± SD of 25.89 ± 27.09and the median was 14.30 (3.0 – 45.0) . No patients reported grade IV toxicity during Modified FOLFIRINOX- losartan induction, with only grade I (42%), GII (14%) and GIII (6%) toxicity in the form of G III diarrhea and Febrile neutropenia. Response after completion CCRT was assessed. (6%) of patients achieved complete response. (38%) of the patients had a partial response, while twenty-four patients (48%) had stable disease and (8%) had progressive disease. Out of the 50 patients, thirteen (26%) patients underwent surgery, with R0 resection achieved in 6 of 13 patients. Median follow-up period was 20.25 months (range, 6.0-34.5). The median PFS for all cohort was 12 months (95% CI, 9.647 – 14.353), while Median OS for all cohort was 21 months (95% CI, (10.200–31.800). The patients who underwent resection had longer OS 24 months (95% CI, (16.363 – 27.637) compared to those who not underwent resection. mean OS was 14 months (95% CI, (9.205 – 18.795)). (P=0.271) The patients who achieved complete response after modified Folforinox-Losartan had longer OS 33months (95% CI, 19.918 – 46.082) compared to who had PR and SD. Median OS was 13, 13 months respectively (95% CI, 6.768 – 19.232), (11.718 – 14.282). (P=0.040*) The patients who achieved CR after CCRT had longer OS (NR) compared to who had PR, SD and PD. median OS was 24, 14 and 8 months respectively (95% CI, 6.761 – 41.239), (11.022 – 16.978), and (95% CI, 4.080 – 11.920) .(P=<0.001*) The patients who achieved complete response after CCRT had longer PFS (NR) compared to who had PR, SD and PD. Median PFS was 24(95% CI, 13.191 – 34.809), 10(95% CI, 4.973 – 15.027) and 5 (95% CI,4.823-5.124) months respectively. (P=<0.001*) Overall, losartan may be considered a promising agent to be used as an adjuvant to standard treatments for PDAC. |