Phase
Condition
Adenocarcinoma
Treatment
RR001
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with confirmed pancreatic ductal adenocarcinoma classified as locallyadvanced 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 anoncologist, radiologist and a qualified digestive surgeon and accounting forAJCC/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 suitablefor 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)treatment
Patient older than 18 years of age
Adequate hepatic and kidney function/Safe hematologic profile
Negative serum pregnancy test for females of childbearing potential
Willingness and ability to comply with the scheduled visits, treatment plan, imagingprocedures, laboratory tests and other study procedures, including lipoaspiratecollection (liposuction)
Exclusion
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 Palliduminfections
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 includingmyocardial infarction, unstable or severe stable angina pectoris
Uncontrolled hypertension
Other malignancies within the past 2 years (not including basal cell carcinoma ofthe 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 studytreatment
Patient has had major open surgery prior to the administration of study treatment
Uncontrolled intercurrent illness including but not limited to psychiatricillness/social situations that in the opinion of the Investigator would compromisecompliance of study requirements or put the patient at unacceptable risk
Study Design
Study Description
Connect with a study center
Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena
Modena, 41124
ItalyActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.