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Pancreatic AdenocarcinomaPhase 2NCT04926467

Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

A Phase 2 study testing Anakinra in people with Pancreatic Adenocarcinoma, run by Baylor Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Anakinra
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
23 Jul 2021to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:
  • 18 years of age or older
  • Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
  • Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
  • American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
  • Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 1
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  • Serum albumin ≥2.0 g/dL.
  • Adequate hematologic function as defined by:
  • Absolute neutrophil count (ANC) ≥1500/mm3;
  • Platelets ≥70,000 x 10^3/µl;
  • Hemoglobin ≥9 g/dL (in the absence of red blood transfusion).
  • Adequate liver function, as defined by:
  • Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
  • ALT (SGPT) and AST (SGOT) ≤2.5 x upper limit of normal (ULN).
  • Adequate renal function, as defined by serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
  • Women of child bearing potential and men must agree to use contraception throughout the study and for one month after the last anakinra administration.
  • Subjects must understand and sign the informed consent form
  • Patients must be accessible for treatment and follow-up.

Who cannot join

  • A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
  • <18 years of age
  • History of organ transplant.
  • Patients with islet cell neoplasms
  • Patients with stage IV pancreatic carcinoma
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
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  • Known active infection with hepatitis B or hepatitis C
  • Presence of clinically significant cirrhosis as determined by the investigator
  • Known HIV positive status.
  • Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
  • Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study
  • Prior chemotherapy or radiation for pancreatic cancer
  • History of allergy or hypersensitivity to the study drugs
  • 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
  • Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor
  • 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.
  • Significant cardiac disease (uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias) within the last six months.
  • 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
  • Peripheral sensory neuropathy > or equal to grade 2 at baseline
  • Abnormal liver function tests as follows:
  • Total bilirubin of > 2 x ULN
  • AST or ALT > 5x ULN
  • Serum albumin ˂ 2.0 g/dL.
  • Abnormal hematologic function as follows :
  • Absolute neutrophil count (ANC) ˂ 1500/mm3;
  • Platelets ˂ 70,000 x 10^3/µl;
  • Hemoglobin ˂ 9 g/dL (in the absence of red blood transfusion).
  • Pregnant or nursing women
  • No signed Informed consent form

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Page Blas, MA contact

(214) 818-7879

page.blas@bswhealth.org

Joyce Ghormley contact

(214) 818-8961

Joyce.Ghormley@BSWHealth.org

United States1 site, 1 recruiting

  • Baylor University Medical Center, Charles A Sammons Cancer Center

    Dallas, Texas, 75246

    Solid Tumor Team, corcsolidtumor@bswhealth.org

    Recruiting

Other trials in United States

About this study

Official title: An Open Label, Phase II Study of Chemotherapy + Anakinra in Patients With Resectable, Locally Advanced or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)

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.

Read the detailed description

This is an open-label, single-arm, prospective phase II study conducted by Baylor Scott and White Research Institute in Dallas.

The study will enroll patients with pancreatic adenocarcinoma that are planned to receive pre-operative chemotherapy followed by surgical resection and post operative treatment. Local surgical/biopsy and pathology reports will constitute adequate documentation of histology/cytology for study inclusion.

Patients will receive pre- and post-operative chemotherapy plus Anakinra. Specifically, the pre-operative chemotherapy regimen will be a combination of Nab-paclitaxel, gemcitabine and cisplatin, while post-operative chemotherapy will use 5-Fluorouracil, oxaliplatin, and irinotecan. Patients will also receive growth factor (Neupogen followed by Neulasta) for safety and to ensure that treatment is not delayed due to neutropenic effects of chemotherapy.

Anakinra will be self-administered by the participants through out the treatment period. A treatment break of 2 days will be given prior to the surgery day.

Being tested
Anakinra

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnakinraDrug

    Also called Kineret

    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.

Study groups in NCT04926467
Study groupRoleWhat they receive
Anakinra plus ChemotherapyExperimentalPatients 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.
Receives: Drug: Anakinra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

Secondary outcomes (7)

  1. To determine the effect of anakinra in combination with perioperative chemotherapy on overall survival (OS) of PDAC patients. A benchmark of 24 months OS will be used to determine how many patients meet or exceed this goal.

    Measured: 24 months

  2. To determine the effect of anakinra in combination with perioperative chemotherapy on the median disease free survival (DFS). A benchmark of 12 months DFS will be used to determine how many patients meet or exceed this goal.

    Measured: 12 months

  3. To determine the effect of anakinra in combination with perioperative chemotherapy on response rate

    Measured: 24 months

  4. To determine the R0 resection rates (complete tumor removal with negative resection margins) obtained with anakinra + pre-operative chemotherapy.

    Measured: 24 months

  5. To describe the effect of anakinra in combination with perioperative chemotherapy on the prevalence and severity of pain by monitoring patients' pain level using memorial pain assessment card (MPAC).

    Measured: 24 months

  6. To determine the effect of anakinra in combination with perioperative chemotherapy on patients' health-related quality of life by monitoring patients using EORTC quality of life survey questionnaire (EORTC QLQ-C30).

    Measured: 24 months

  7. To determine the effect of anakinra in combination with perioperative chemotherapy on the inflammasomes ( IL6, CRP, IL1α and IL1β) in blood and in the resected pathology specimens.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2021
  2. Study start23 Jul 2021
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04926467
Sponsor's protocol ID
020-476
Status last verified
Oct 2026
First submitted
1 Jun 2021
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anakinra in people with Pancreatic Adenocarcinoma, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Page Blas, MA ((214) 818-7879, page.blas@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04926467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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