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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT04926467
Eligibility Criteria:
Inclusion Criteria:
* A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:
1. 18 years of age or older
2. Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
3. Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
4. American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
5. Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 1
6. Serum albumin ≥2.0 g/dL.
7. Adequate hematologic function as defined by:
1. Absolute neutrophil count (ANC) ≥1500/mm3;
2. Platelets ≥70,000 x 10\^3/µl;
3. Hemoglobin ≥9 g/dL (in the absence of red blood transfusion).
8. Adequate liver function, as defined by:
1. Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
2. ALT (SGPT) and AST (SGOT) ≤2.5 x upper limit of normal (ULN).
9. Adequate renal function, as defined by serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
10. Women of child bearing potential and men must agree to use contraception throughout the study and for one month after the last anakinra administration.
11. Subjects must understand and sign the informed consent form
12. Patients must be accessible for treatment and follow-up.
Exclusion Criteria:
* A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
1. \<18 years of age
2. History of organ transplant.
3. Patients with islet cell neoplasms
4. Patients with stage IV pancreatic carcinoma
5. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
6. Known active infection with hepatitis B or hepatitis C
7. Presence of clinically significant cirrhosis as determined by the investigator
8. Known HIV positive status.
9. Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
10. Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study
11. Prior chemotherapy or radiation for pancreatic cancer
12. History of allergy or hypersensitivity to the study drugs
13. Patient is enrolled in any outside therapeutic clinical protocol or investigational trial with an investigational drug within 5 half-lives prior to Study ID assignment
14. Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor
15. Other malignancy within five years(except cutaneous, non-melanoma malignancies or cervical carcinoma in site), unless the probability of recurrence of the prior malignancy is \<5% as determined by the Principal Investigator based on available information.
16. Significant cardiac disease (uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias) within the last six months.
17. Other severe and/or uncontrolled medical conditions (e.g: prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation) or other conditions deemed by investigator as unsuitable for participation/enrollment
18. Peripheral sensory neuropathy \> or equal to grade 2 at baseline
19. Abnormal liver function tests as follows:
1. Total bilirubin of \> 2 x ULN
2. AST or ALT \> 5x ULN
20. Serum albumin ˂ 2.0 g/dL.
21. Abnormal hematologic function as follows :
1. Absolute neutrophil count (ANC) ˂ 1500/mm3;
2. Platelets ˂ 70,000 x 10\^3/µl;
3. Hemoglobin ˂ 9 g/dL (in the absence of red blood transfusion).
22. Pregnant or nursing women
23. No signed Informed consent form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04926467
Study Brief:
Protocol Section:
NCT04926467