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:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT05181605
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors
* 2\. Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA) performed by Echoendoscopy.
* 3\. Patients who have not received prior therapy for pancreatic cancer.
* 4\. Biliary drainage prior to neoadjuvant treatment.
* 5\. Age\> 18 years and \<70 years.
* 6\. No history of cerebrovascular accident (CVA) or myocardial infarction (MI) in 6 months prior to neoadjuvant treatment.
* 7\. Women of childbearing potential and sexually active men must agree to the use of appropriate contraceptive methods (hormonal, barrier, or abstinence) prior to study enrollment and during study participation.
* 8\. Patients should have normal organs and spinal function.
* 9\. Ability to understand, and willingness to sign a written informed consent document
Exclusion Criteria:
* 1\. Patients with resectable pancreatic adenocarcinoma without risk factors.
* 2\. Patients with borderline pancreatic adenocarcinoma.
* 3\. Patients with locally advanced pancreatic adenocarcinoma.
* 4\. Patients with metastatic adenocarcinoma of the pancreas.
* 5\. Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
* 6\. Pathological subtypes other than adenocarcinoma.
* 7\. Patients included in a clinical trial in a period of 6 months prior to inclusion in this study.
* 8\. A past history of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition.
* 9\. Uncontrolled breakthrough disease.
* 10\. Patients with HIV, HBV and HCV positive and currently under antiretroviral therapy.
* 11\. Other active malignancies
* 12\. Pre-existing neuropathy, grade \> 1.
* 13\. Inflammatory bowel disease that is not controlled, or under current active therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05181605
Study Brief:
Protocol Section:
NCT05181605