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Chemotherapy

Chemotherapy + Anakinra for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Carlos Becerra, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal function: serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test whether the addition of the drug anakinra to standard chemotherapy can improve outcomes for patients with pancreatic cancer.

Who is the study for?
Adults with resectable or locally advanced pancreatic adenocarcinoma (stages I-III) can join. They must be in good health overall, with specific blood and organ function criteria met. Participants need to agree to use contraception during the study and for a month after, and they cannot have had prior treatments for their cancer.Check my eligibility
What is being tested?
The trial is testing Anakinra combined with chemotherapy in patients undergoing surgery for pancreatic cancer. It's based on how inflammation affects pancreas cancer and aims to see if blocking certain inflammatory signals can help improve treatment outcomes.See study design
What are the potential side effects?
Anakinra may cause reactions at the injection site, increased risk of infections due to immune system suppression, headaches, nausea, diarrhea, joint pain or swelling. The side effects from chemotherapy could include fatigue, hair loss, mouth sores and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the normal range.
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My pancreatic cancer can potentially be removed with surgery.
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My liver tests are within the normal range.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My pancreatic cancer is at an early to mid-stage (Stage I-III).
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My cancer is primarily pancreatic ductal adenocarcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Pharmacotherapy
To determine the R0 resection rates (complete tumor removal with negative resection margins) obtained with anakinra + pre-operative chemotherapy.
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.
+4 more

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

Trial Design

1Treatment groups
Experimental Treatment
Group I: Anakinra plus ChemotherapyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
FDA approved

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
198 Previous Clinical Trials
202,728 Total Patients Enrolled
Carlos Becerra, MDPrincipal InvestigatorCharles A. Sammons Cancer Center/Texas Oncology
5 Previous Clinical Trials
69 Total Patients Enrolled

Media Library

Perioperative Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04926467 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: Anakinra plus Chemotherapy
Pancreatic Adenocarcinoma Clinical Trial 2023: Perioperative Chemotherapy Highlights & Side Effects. Trial Name: NCT04926467 — Phase 2
Perioperative Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04926467 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a risk of serious side effects from using Anakinra?

"The safety of Anakinra falls in the middle of our 1-3 scale because, while there is data attesting to its safety, Phase 2 trials have yet to establish any efficacy."

Answered by AI

Anakinra is most often used for what reason?

"Anakinra is frequently used to manage sjia, but it can also be an effective treatment for nomid, receptors, interleukin-1, and steroid responses."

Answered by AI

Are we still taking patients for this experiment?

"This study is not admitting patients at this time. This information was last updated on June 8th, 2021. There are currently 806 other clinical trials for adenocarcinoma and 34 trials testing Anakinra that are actively recruiting patients."

Answered by AI

How many test subjects are enrolling in this clinical trial?

"This trial is no longer enrolling patients. The study was originally posted on June 1st, 2021 and edited for the last time on June 8th, 2021. For other options, there are 806 trials related to adenocarcinoma and 34 studies involving Anakinra that are still recruiting participants."

Answered by AI

What other drug studies has Anakinra been a part of in the past?

"At this moment, there are 34 ongoing clinical trials studying Anakinra. Out of those, 6 have progressed to the third and final stage. Many of these experiments originated in Paris but have since spread to 440 different locations."

Answered by AI
~7 spots leftby Jun 2025