ag vs mfolfirinox as neoadjuvant therapy for borderline reseactable and locally advanced pancreatic cancer

Conditions: Borderline Resectable Pancreatic Cancer; Locally Advanced Pancreatic Adenocarcinoma

Summary: this is a prospective, single-center, randomized, controlled phase ⅲ study.

three hundred patients with borderline resectable and locally advanced pancreatic cancer will be randomized 1:1 (150 :150) to the ag and mfolfirinox chemotherapy groups and to observe the overall survival. the ag regimen: albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles. mfolfirinox: intravenous oxaliplatin for 2 hours, day 1;intravenous infusion of calcium formyl tetrahydrofolate (lv) for 2 h, day 1;irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;intravenous infusion of 5-fluorouracil (5-fu) continued for 46 hours.repeat every 2 weeks for a total of 4-6 cycles. after neoadjuvant chemotherapy, the surgery will be evaluated according to the patient's tumor and systemic condition. the first cycle of adjuvant chemotherapy begins 4-8 weeks after radical resection, and the choice of adjuvant chemotherapy regimen depends on the response to neoadjuvant chemotherapy.if neoadjuvant chemotherapy is effective, adjuvant chemotherapy maintains the original regimen.adjuvant chemotherapy has 4 cycles of treatment. relevant examinations were performed before and after each cycle of medication to assess safety events, imaging review was performed every 2 cycles during the treatment period and every 3 months during the follow-up period.

Eligibility criteria:
inclusion criteria: * signed informed content obtained prior to treatment * age ≥18 years and ≤ 80 years * eastern cooperative oncology group (ecog) performance status ≤1 * radiographically confirmed after borderline resectable or locally advanced pancreatic adenocarcinoma. * no any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy. * no any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy. * no serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards) * white blood cell (wbc) ≥ 3 × 109/l; absolute neutrophil count (anc) ≥ 1.5 × 109/l; platelets (plt) ≥ 100 × 109/l; hemoglobin (hgb)≥ 9 g/dl * aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\]/alanine aminotransferase (alt) (serum glutamic pyruvate transaminase \[sgpt\]) ≤ 2.5 × institutional upper limit of normal (uln); total bilirubin (tbil) ≤ uln; creatinine (cre) ≤ 1.5 × uln * prothrombin time (pt) and international normalized ratio (inr) ≤ 1.5 ×uln * comply with research visit plans and other program requirements. exclusion criteria: * with other systemic malignancies * patients who were treated with any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy. * used any other study drug within 7 days prior to enrollment; * patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled * history of allergic reactions attributed to compounds of similar chemical or biological composition to study drug and alike. * patients who are using and expected to use warfarin in long term * patients may leave the observation for 14 days or more during the study.

Keywords: neoadjuvant chemotherapy albumin bound paclitaxel mfolfirinox