About this trial
RR001, a cell-based gene therapy administered following chemotherapy cycles for the treatment of patients with locally advanced pancreatic cancer. Phase I /IIa clinical trial (open label and non-randomized) to test the effects (safety \& efficacy) of increasing doses of RR001
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RR001