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

Borderline Resectable Pancreatic Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Borderline Resectable Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT06387810
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Contact: Wenming Wu, doctor
• Phone: +86 010-69156053
• Email: doctorwuu@126.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 17, 2024
• Completion date: June 30, 2026