AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer
NCT04617821 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2022-01-28
Summary
This is a prospective, single-center, randomized, controlled phase Ⅲ study.
Conditions
- Borderline Resectable Pancreatic Cancer
- Locally Advanced Pancreatic Adenocarcinoma
Interventions
- DRUG
-
Nab paclitaxel plus gemcitabine
Albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycle.
- DRUG
-
mFOLFIRINOX
Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Xian-Jun Yu, MD, PhD · Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-01
- Primary Completion
- 2024-09-30
- Completion
- 2024-09-30
Countries
- China
Study Locations
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