Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases

Inclusion Criteria:

• Age ≥ 18 years;
• Willing and able to provide written and informed consent;
• Histological or cytological proof of pancreatic cancer;
• Metastatic disease with peritoneal carcinomatosis determined by the treatingphysician, based on abdominal CT or MR and/or diagnostic laparotomy or laparoscopy;
• Evaluable disease defined by RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• Life expectancy of at least 3 months;
• No contraindication for laparoscopy;
• No contraindication for drugs used in the study;
• Adequate bone marrow function: Absolute neutrophil count ≥ 1500 cell./mm3; Platelets ≥ 100000 cell./mm3;
• Hemoglobin ≥ 9 g/dl
• Adequate renal function (serum creatinine up to 1.5 times the maximal limit of thelocal laboratory) or else based upon clinical evaluation;

Exclusion Criteria:

• Advanced metastatic systemic disease with clinical deterioration;
• Patients with extraabdominal tumor spread;
• Patients with a germline or somatic pathogenic variant involving an (HomologousRecombination Repair) HRR-related gene;
• Symptoms of gastrointestinal occlusion and total parenteral nutritional support;
• Patients defined as "refractory" to previous systemic treatment with Nab-paclitaxeland Gemcitabine administered for locally advanced pancreatic cancer (patients treatedwith Nabpaclitaxel-Gemcitabine for a locally advanced disease may be included if PMdeveloped after at least 6 months from the end of previous chemotherapy);
• History of severe and unexpected reactions to Nabpaclitaxel or Gemcitabine derivates
• Known hypersensitivity reaction to drugs chemically related to Nabpaclitaxel,Gemcitabine and their excipients;
• Severe cardiac disease (recent myocardial ischemia, severe cardiac arrhythmias, severecardiac failure);
• Clinical disease progression after first 2 months of systemic NabpaclitaxelGemcitabine chemotherapy;
• Any concurrent severe, acute, or chronic medical or psychiatric condition orlaboratory abnormality that may increase the risk of associated with studyparticipation or investigational product administration or may interfere withcompliance with study procedures or the interpretation of study results and, in thejudgment of the investigator, would make the subject inappropriate for entry into thestudy;