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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07477418
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).
* Borderline resectable disease as defined by the ABC classification criteria, incorporating one or more of the following:
* Anatomy (A): Vascular involvement consistent with borderline resectable or resectable locally advanced-PDAC (e.g., abutment of the superior mesenteric vein or artery, portal vein, or celiac axis) as determined by cross-sectional imaging
* Biology (B): Concern for extra-pancreatic metastasis or known N1 disease or suspicious but nonconfirmatory liver/lung lesion(s). CA19-9\>500 after normalized bilirubin
* Condition (C): Functional status and comorbidity profile adequate for curative-intent surgery, as assessed by the multidisciplinary team, specifically WHO PS \>/=1.
* No prior treatment for PDAC (e.g., chemotherapy, radiation, or surgery).
* Age ≥ 18 years.
* ECOG performance status of 0 or 1.
* Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
* Locally Advanced PDAC or metastatic PDAC
* Histology other than adenocarcinoma
* Non-accessible arterial anatomy
* Gemcitabine hypersensitivity or contraindication to mFOLFIRINOX therapy based on provider assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07477418
Study Brief:
Protocol Section:
NCT07477418