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Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

NCT04926467 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-10

No results posted yet for this study

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 gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

Anakinra

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.

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • A. Scott Paulson, MD · Charles A. Sammons Cancer Center/Texas Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04926467 on ClinicalTrials.gov