Recruiting
Phase 2

Anakinra with Chemotherapy

Sponsor:

Baylor Research Institute

Code:

NCT04926467

Conditions

Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anakinra

Study Details

Brief summary:

Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.

Conditions

Pancreatic Adenocarcinoma

Study ID

NCT04926467

Start date

Jul 23, 2021

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Anakinra plus Chemotherapy

Patients will receive Anakinra during both pre-operative chemotherapy with Nab-paclitaxel, gemcitabine and cisplatin, followed by surgery and post-operative chemotherapy with 5-fluorouracil, oxaliplatin, and irinotecan.

Interventions

Anakinra

Anakinra (100 mg) twice a day (BID), daily, will be self-administered subcutaneously starting on D1 of chemotherapy. Anakinra will be held 2 days prior to surgery. A dosing diary will be given to the patient for anakinra documentation.

Primary outcome measure

  • To determine the percentage of patients that have a normalization of CA19-9 after pre-op treatment with the combination of nab-paclitaxel (abraxane), gemcitabine, cisplatin and anakinra. [ Time Frame: 24 months ]

Central Contacts and Locations

Locations

Baylor University Medical Center, Charles A Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

More Information

Sponsor

Baylor Research Institute

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2025-11-10.