This phase II study is designed to evaluate the efficacy and safety of modified FOLFIRINOX as neoadjuvant treatment for resectable pancreatic cancer.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients with pancreatic ductal adenocarcinoma confirmed by histological or cytopathological examination
2. Pancreatic adenocarcinoma patients evaluated as resectable according to the following criteria in imaging tests including CT or MRI (NCCN guideline criteria, if all of the following criteria are satisfied) A. No tumor contact with the major arterial structures of the Celiac axis \[CA\], superior mesenteric artery \[SMA\], and common hepatic artery \[CHA\].
B. When there is no contact between the tumor and the major vein of the superior mesenteric vein (SMV) or portal vein (PV), or within 180° even if there is contact, and there is no venous atypicality.
3. Patients who have not undergone surgical resection and systemic chemotherapy for pancreatic cancer.
4. Patients whose ECOG activity ability index is 0 to 1
5. Patients who are willing and able to provide written informed consent for this study.
6. Patients over the age of 19 at the time of signing the subject consent form.
7. Patients with evaluable lesions according to RECIST 1.1.
8. Patients with adequate organ function.
You may not be if
1. Histologic diagnosis other than pancreatic ductal adenocarcinoma (eg, neuroendocrine tumor, etc.)
2. Patients with distant metastases including central nervous system (CNS) metastases or peritoneal metastases
3. Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
4. Patients who have participated in a study in which investigational drugs are used and are currently receiving investigational drugs or used investigational drugs or medical devices within 4 weeks prior to the first administration of this investigational drug.
5. Those who received chemotherapy, targeted small molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 or lower or baseline level) from adverse reactions due to previously administered drugs patient.
6. Patients with known aggravation within the past 3 years or other malignant tumors requiring active treatment.
Clareo Health | A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma
