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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT03941093
Eligibility Criteria:
Inclusion Criteria:
1. Understand and sign informed consent; be willing to comply with study procedures, including surgery
2. Age ≥ 18 years
3. Be a male, or non-pregnant and non-lactating female
4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential
5. Male participants with partners of childbearing potential and female participants of childbearing potential are required to use highly effective contraception methods during the conduct of the study and for 6 months after the last dose of study drug
6. Histologically or cytologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
7. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging
8. Measurable disease as defined by RECIST 1.1 criteria as determined by central imaging
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
10. Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x upper limit of normal (ULN), alkaline phosphatase \<2.5 x ULN, and bilirubin ≤1.5 x ULN or in participants with biliary stenting ≤2.0 x ULN
11. Adequate bone marrow function: platelets \>100,000 cells/mm3, hemoglobin \>9.0 g/dl and absolute neutrophil count (ANC) \>1,500 cells/mm3
12. Adequate renal function: creatinine \< 1.5 x ULN, creatinine clearance ≥ 30 mL/min
13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)
Exclusion Criteria:
1. Prior chemotherapy or radiation for pancreatic cancer
2. Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
3. Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.
4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
5. History of allergy or hypersensitivity to any of the chemotherapy agents being prescribed or their excipients
6. Any medical or surgical condition that may place the participant at increased risk while on study
7. Any condition potentially decreasing compliance to study procedures
8. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half-lives of the investigational drug (whichever is longer)
9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
10. Documented history of drug or alcohol abuse within 6 months of signing informed consent
11. Any medical condition that, in the opinion of the investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation
12. Participants with a history of interstitial pulmonary disease, hepatitis C virus (HCV), hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection
13. Participants who have been administered a live vaccine within 4 weeks prior to the first administration of therapy
14. Participants who cannot stop chronic medications that inhibit or induce cytochrome P (CYP) 2C8 or CYP3A4
15. Participants with poorly controlled comorbid conditions, including; congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) or limited function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03941093
Study Brief:
Protocol Section:
NCT03941093