24
Participants
Start Date
June 30, 2021
Primary Completion Date
June 30, 2025
Study Completion Date
June 30, 2026
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."
Baylor University Medical Center, Charles A Sammons Cancer Center, Dallas
Lead Sponsor
Baylor Research Institute
OTHER