Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT02592395
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically proven pancreatic carcinoma which is safely accessible by percutaneous methods;
* Locally advanced un-resectable pancreatic adenocarcinoma;
* At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (longest diameter \>=20 mm using conventional techniques or \>=10 mm with spiral CT or MRI scan);
* WHO performance status (PS) \< 2 or Eastern Cooperative Oncology Group \< 2;
* Age \>18;
* Life expectancy \> 3 months;
* No history of gastric or esophageal varices;
* No active, uncontrolled infection;
* All patients must have adequate physiologic (hematologic, renal and hepatic) reserves as evidenced by: neutrophil count \>1500/mL; platelet count \>100,000/mL; serum creatinine \<1.5x the upper limit of normal (ULN) value; serum glutamic-pyruvic transaminase (SGPT) \<2.5 x ULN and bilirubin \<1.5 x ULN functions
* Pain and biliary obstruction controlled before the start of the study
* Absence of psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
* Women of childbearing potential (defined as sexually mature woman who 1) has not undergone hysterectomy \[the surgical removal of the uterus\] or bilateral oophorectomy \[the surgical removal of both ovaries\] or 2) has not been naturally post-menopausal for at last 24 consecutive months) must have a negative pregnancy test prior to starting therapy. Men and women of childbearing potential must be willing to use effective contraceptive while on treatment and for a reasonable period thereafter.
Exclusion Criteria:
* Prior chemotherapy with FOLFIRINOX;
* Prior history of pancreatic electroporation;
* Untreatable contrast allergy;
* History of allergy or hypersensitivity to gemcitabine, nab-paclitaxel, or any of the excipients;
* Presence of metal biliary stent;
* Psychosis or seizures;
* Evidence of serious gastrointestinal bleeding or bowel obstruction;
* Pregnant or lactating women;
* Women of childbearing potential who are not using adequate protection;
* Inability to tolerate MRI imaging
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02592395
Study Brief:
Protocol Section:
NCT02592395