New gene therapy tackles tough pancreatic cancer

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with confirmed pancreatic ductal adenocarcinoma classified as locally advanced pancreatic adenocarcinoma (LPAC) * Patients with no evidence of peritoneal or hematogenous metastasis * Patients classified as non-resectable locally advanced pancreatic carcinoma (LAPC) based on imaging (TC and NMR), on multidisciplinary staff evaluation by at least an oncologist, radiologist and a qualified digestive surgeon and accounting for AJCC/UICC TNM and clinical staging * Measurable tumor according RECIST criteria v 1.1 * Low tumor burden with at least one lesion equal/less than 3,5 cm that is suitable for US guided injection (and needle biopsy). * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Patients must be eligible for chemotherapy treatment (based on standard of care) * Patient older than 18 years of age * Adequate hepatic and kidney function/Safe hematologic profile * Negative serum pregnancy test for females of childbearing potential within days of starting treatment * Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate collection (liposuction) Exclusion Criteria: * Patient with pancreatic cystic tumor or pancreatic pseudocyst * Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases) * Patients with unknown stage or recurrent pancreatic cancer * Patients with immunosuppression or susceptibility to viral infection * Patients with HIV, hepatitis B, hepatitis C, HTLV-I/II, Treponema Pallidum infections * Patients with liver cirrhosis or other documented liver diseases * Patient contraindication to use chemotherapy treatments * Previous of radiotherapy and chemotherapy for PDAC * Previous hematopoietic stem cell or organ transplantation * Irreversible cardiac arrhythmias requiring permanent medication * Heart insufficiency (\> grade II, New York Heart Association NYHA criteria) * History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris * Uncontrolled hypertension * Other malignancies within the past 2 years (not including basal cell carcinoma of the skin, prostate cancer or in situ cervix carcinoma, in situ melanoma). * Active autoimmune disease * Use of any investigational agents within 21 days from the administration of study treatment * Patient has had major open surgery prior to the administration of study treatment * Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk * Suspected or known allergy or hypersensitivity to fluoroquinolones including but not limited to ciprofloxacin * Suspected or known allergy or hypersensitivity to protamine sulfate or protamine containing products. Including but not limited to patients who have previously undergone procedures such as coronary angioplasty or cardio-pulmonary bypass, which may involve the use of protamine, diabetics who have been treated with protamine insulin, patients allergic to fish, and men who have undergone a vasectomy or are infertile and may have antibodies to protamine