Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer
NCT06387810 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2024-07-10
Summary
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients.
Conditions
Interventions
- DRUG
-
irinotecan liposome II combined with 5-FU/LV and oxaliplatin
irinotecan liposome II: 60mg/m2, intravenously for at least 90min, D1, administered every 2 weeks; oxaliplatin: 85 mg/m2, intravenous infusion, D1, every 2 weeks; calcium leucovorin: 400 mg/m2, 30±10min intravenously, D1, every 2 weeks; 5-fluorouracil: 2400 mg/m2 intravenously for 46-48 hours or according to study Center clinical practice, D1, administered every 2 weeks. Irinotecan liposome II, oxaliplatin, LV and 5-FU were given successively, and corresponding prophylactic administration could be selected according to clinical needs.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Wenming Wu, doctor · Peking Union Medical College Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 110 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-17
- Primary Completion
- 2026-04-30
- Completion
- 2026-06-30
Countries
- China
Study Locations
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