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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
Must not have
Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will test if adding Anakinra, an anti-inflammatory medication, to chemotherapy can improve treatment 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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery or any vascular device placement in the last 2 weeks.
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I do not have any ongoing serious infections requiring treatment.
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I am HIV positive.
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I have an active hepatitis B or C infection.
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I am currently on medication that suppresses my immune system.
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I have a tumor in the cells that make insulin in my pancreas.
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I have had an organ transplant.
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I am under 18 years old.
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My pancreatic cancer is at stage IV.
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I have not had serious heart issues like heart failure or heart attack in the last 6 months.
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I am allergic to the medication used in this study.
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I have moderate to severe numbness or tingling in my hands or feet.
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I have been treated with anakinra, canakinumab, or another IL-1 inhibitor.
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I have had chemotherapy or radiation for pancreatic cancer.
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My doctor has diagnosed me with serious liver cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Pancreatic Adenocarcinoma (PDAC) include chemotherapy regimens such as FOLFIRINOX and gemcitabine combined with nab-paclitaxel. FOLFIRINOX works by combining multiple chemotherapeutic agents to inhibit cancer cell division and promote cell death, while gemcitabine interferes with DNA replication in cancer cells. Nab-paclitaxel enhances the delivery of chemotherapy to the tumor. Inflammation plays a central role in PDAC progression, with IL-1 being a key driver. Anakinra, an IL-1 inhibitor, is being studied for its potential to reduce inflammation and improve outcomes when combined with chemotherapy. This matters for PDAC patients as targeting inflammation alongside traditional chemotherapy may enhance treatment efficacy and potentially improve survival rates.
Differential role of Interleukin-1 and Interleukin-6 in K-Ras-driven pancreatic carcinoma undergoing mesenchymal transition.

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,401 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
~3 spots leftby Jun 2025