Last updated: August 5, 2022
Sponsor: Instituto de investigación e innovación biomédica de Cádiz
Overall Status: Active - Recruiting
Phase
2/3
Condition
Pancreatic Cancer
Pancreatitis
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT05181605
ICI20-00047
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors
- Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA)performed by Echoendoscopy.
- Patients who have not received prior therapy for pancreatic cancer.
- Biliary drainage prior to neoadjuvant treatment.
- Age> 18 years and <70 years.
- No history of cerebrovascular accident (CVA) or myocardial infarction (MI) in 6months prior to neoadjuvant treatment.
- Women of childbearing potential and sexually active men must agree to the use ofappropriate contraceptive methods (hormonal, barrier, or abstinence) prior to studyenrollment and during study participation.
- Patients should have normal organs and spinal function.
- Ability to understand, and willingness to sign a written informed consent document
Exclusion
Exclusion Criteria:
- Patients with resectable pancreatic adenocarcinoma without risk factors.
- Patients with borderline pancreatic adenocarcinoma.
- Patients with locally advanced pancreatic adenocarcinoma.
- Patients with metastatic adenocarcinoma of the pancreas.
- Patients who have received prior chemotherapy or radiotherapy for pancreaticadenocarcinoma
- Pathological subtypes other than adenocarcinoma.
- Patients included in a clinical trial in a period of 6 months prior to inclusion inthis study.
- A past history of allergic reaction attributed to 5-FU, leucovorin, Irinotecan orOxaliplatin or to compounds of similar chemical or biological composition.
- Uncontrolled breakthrough disease.
- Patients with HIV, HBV and HCV positive and currently under antiretroviraltherapy.
- Other active malignancies
- Pre-existing neuropathy, grade > 1.
- Inflammatory bowel disease that is not controlled, or under current activetherapy.
Study Design
Total Participants: 116
Study Start date:
April 15, 2022
Estimated Completion Date:
December 01, 2024
Study Description
Connect with a study center
Hospital Puerta del Mar
Cádiz, 11010
SpainActive - Recruiting
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