Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

Conditions
Pancreatic Adenocarcinoma
Interventions
DRUG

Anakinra

"Pre-operative treatment: Nab-paclitaxel (125 mg/m2), gemcitabine (1000 mg/m2), and cisplatin (25 mg/m2) will be given on Day 1 and 8 of a 21-day cycle. Patients will receive anakinra 100 mg injection twice a day starting on day 1 of chemotherapy. Anakinra will be self-administered by the patients and will be discontinued 2 days prior to surgery. Total number of cycles = 4.~Post-operative treatment: 5-Fluorouracil (2400 mg/m2 CI for 48 hours), oxaliplatin (85 mg/m2), and irinotecan (150 mg/m2) will be given once every 2 weeks (1 cycle =14 days). Patients will receive anakinra 100 mg injection subcutaneously twice a day starting on day 1 of chemotherapy (initiated within 4-8 weeks after surgery). Anakinra will be self-administered by the patient throughout the treatment without any break. Total number of cycles = 8."

Trial Locations (1)

75246

Baylor University Medical Center, Charles A Sammons Cancer Center, Dallas

Sponsors
All Listed Sponsors
lead

Baylor Research Institute

OTHER