Could an arthritis drug help fight pancreatic cancer?
NCT ID NCT04926467
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether adding the drug anakinra (Kineret) to standard chemotherapy can improve outcomes for people with pancreatic cancer that can be surgically removed or is locally advanced. Anakinra is an anti-inflammatory drug typically used for rheumatoid arthritis. The study will enroll 24 adults and measure how well the treatment normalizes a key tumor marker (CA19-9) and improves survival. Participants will receive the drug combination before and after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anakinra (Kineret) plus chemotherapy (nab-paclitaxel, gemcitabine, cisplatin)
- What this could lead to
- If successful, this combination could improve survival rates and help more patients become eligible for surgery, potentially extending life for those with pancreatic cancer.
- What could go wrong
- This is a small, early-phase trial with only 24 participants, so results may not apply broadly. Anakinra can cause injection site reactions and increase infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor University Medical Center, Charles A Sammons Cancer Center
RECRUITINGDallas, Texas, 75246, United States
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