Randomized phase II trial of neoadjuvant chemotherapy with modified FOLFIRINOX versus modified FOLFIRINOX and PD-1 antibody for borderline resectable and locally advanced pancreatic cancer (the CISPD-4 study).

562 Background: Neoadjuvant chemotherapy is recommended for BRPC and LAPC planned resection. PD-1 antibody alone was failed in advanced pancreatic cancer, but chemotherapy combined with PD-1 antibody are promising. Methods: This is a randomized, controlled, open-label phase II study including patients with BRPC or LAPC. Modified FOLFIRINOX (mFFX) is used as neoadjuvant chemotherapy. Patients will be randomly allocated into two groups: mFFX group and mFFX plus PD-1 antibody group (PD-1 group). Imaging evaluation will be discussed by the MDT. Surgical resection will be performed if the MDT confirms the resectability. (NCT03983057). Results: From March 4, 2019 to August 1, 2021, 146 patients (62 BRPCs and 84 LAPCs) were enrolled. 115 patients received at least four cycles of therapy. In PD-1 group, irAEs happened in seven patients (9.7%), including rash (3 patients, Grade 1), hepatic AE (2 patients Grade 3, 1 patient Grade 2), renal AE (2 patients, Grade 2), and hyperglycemia (2 patients). Radiological PR were noted in 13.3% patients in mFFX group, and 26.9% in PD-1 group. For BRPC patients, the radiological PR was 13.0% and 36.3%, respectively. The resection rate was similar in two groups (47.4% and 51.7%). R0 resections were performed in 70.3% and 86.6% patients, respectively. For LAPC patients, PD-1 group has a higher resection rate (37.1% vs. 48.0%). The survival data are not mature at present. Conclusions: Modified FOLFIRINOX plus PD-1 antibody is feasible and well-tolerated for BRPC and LAPC patients. The study will be continued and the detailed data will be reported. Clinical trial information: NCT03983057.