Study of Irinotecan Liposome with Oxaliplatin and Tegafur as Additional Treatment After Pancreatic Cancer Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of irinotecan liposome injection combined with oxaliplatin and tegafur NASOX as postoperative adjuvant chemotherapy for pancreatic cancer. This study focuses on patients who have undergone surgery to remove pancreatic ductal adenocarcinoma and aims to improve outcomes after surgery. Participants receive irinotecan liposome injection, oxaliplatin, and tegafur as their treatment. Oxaliplatin is given intravenously at 60 mgm2 over 2 hours on day 1 and repeated every 15 days. Irinotecan liposomes are administered intravenously at 50 mgm2 over 90 minutes on day 1, also repeated every 15 days. Tegafur is taken orally at 40-60 mg twice daily from day 1 to day 10, repeating every 15 days. One treatment cycle lasts 30 days, with a total of six cycles planned. During the study, participants will be closely monitored for disease-free survival up to about 21.6 months. Researchers will also track adverse events, overall survival, quality of life, treatment completion rates, and any need to replace tegafur due to intolerance. Safety is assessed using standard criteria over approximately seven months, while survival and quality of life are followed for up to around 55 months after treatment begins.

Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer