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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:
⁃ According to the NCCN Clinical Practice Guidelines for Pancreatic Cancer (2024.V1 edition), patients with critically resectable pancreatic cancer.
⁃ Have at least one measurable lesion as a target lesion (according to RECIST v1.1);
⁃ Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeting, immunotherapy, etc.) or investigational drug therapy;
⁃ ECOG: 0 \
• 1;
⁃ Expected survival ≥3 months;
⁃ Adequate organ and blood function
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Wenming Wu, doctor
doctorwuu@126.com
+86 010-69156053
Backup
+86 010-69156053 Wu, doctor
doctorwuu@126.com
+86 010-69156053
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 45
Treatments
Experimental: Combined treatment group
After screening and signing informed consent, patients who met the admission requirements received 4 cycles of neoadjuvant therapy with irinotecan liposome II combined with 5-FU/LV and oxaliplatin before surgery.~Surgery was performed within 2 to 4 weeks after the end of neoadjuvant therapy. 4 to 6 weeks after surgery, 4 cycles of 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).
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital