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RECRUITING
NCT06387810
PHASE2

Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer:A Prospective, Single-arm, Multicenter, Phase II Study

Key Details

Gender

All

Age Range

18 Years - 110 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-04-17

Completion Date

2026-06-30

Last Updated

2024-07-10

Healthy Volunteers

No

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China