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Could an arthritis drug help fight pancreatic cancer?

NCT ID NCT04926467

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Baylor University Medical Center, Charles A Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

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