NCT06387810

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. After screening and signing informed consent, patients who met the admission requirements received neoadjuvant therapy with irinotecan liposome II combined with 5-FU/LV and oxaliplatin before surgery (once every 2 weeks, every 2 weeks). After completing 4 cycles of preoperative neoadjuvant therapy, surgical evaluation was performed: For patients evaluated for radical surgical resection, surgery was performed within 2 to 4 weeks after the end of neoadjuvant therapy, abdominal enhanced CT/MRI was performed within 4 to 6 weeks after surgery, and postoperative adjuvant therapy with irinotecan liposome II combined with 5-FU/LV and oxaliplatin was performed according to the investigator's judgment (once every 2 weeks, a 2-week cycle). After the completion of 4 cycles of postoperative adjuvant therapy, the tumor progression follow-up/survival follow-up stage was entered. Patients who were assessed as not eligible for radical surgical resection could choose follow-up treatment according to the investigator's judgment, and continue to follow up their survival until withdrawal of informed consent or death.

Conditions

• Borderline Resectable Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-17
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2024-04-29
• Last updated: 2024-07-10

Locations

1 site across 1 country: China