Study of XP-004 Personalized mRNA Vaccine and PD-1 Inhibitor as Additional Treatment After Surgery for Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the safety and tolerability of XP-004 personalized mRNA vaccines combined with a PD-1 inhibitor as additional therapy for patients who have had radical surgery for pancreatic cancer but cannot tolerate chemotherapy. This early phase 1 study also aims to explore preliminary effectiveness by measuring immune response, recurrence-free survival, and overall survival in these patients after surgery. Participants receive a sequence of treatments starting with four cycles of single or fixed target mRNA vaccines targeting common pancreatic cancer mutations, followed by nine cycles of personalized mRNA vaccines tailored to each patients tumor mutations. These vaccines are given alongside a PD-1 inhibitor called Toripalimab every three weeks, totaling 13 treatment cycles. During the study, participants will be closely monitored for drug-related side effects over 18 months. Researchers will assess immune responses by measuring specific T cell activation in the blood and track how long patients remain free from cancer recurrence as well as overall survival. The study involves regular visits for treatment administration, blood tests, and evaluations to understand safety and potential benefits of this combination therapy after pancreatic cancer surgery.

Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer