drugset / Trial / NCT06496373

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

NCT06496373

NaSingle-groupOpen-labelTreatment

Summary

This study primarily aims to assess the safety and tolerability of XP-004 personalized mRNA vaccines encoding tumor neoantigens combined with PD-1 inhibitor as adjuvant therapy for chemotherapy-intolerant patients following radical pancreatic cancer resection. Secondary objectives focus on evaluating preliminary efficacy through three parameters: 1) XP-004-induced antigen-specific CD4+/CD8+ T cell activation levels, 2) recurrence-free survival (RFS), and 3) overall survival (OS) in post-operative pancreatic cancer patients receiving this combination therapy.

Timeline

Start
2024-07-16
Primary completion
2026-06-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fixed neoantigen tumor vaccine Messenger RNA (mRNA)
Subject Personalized neoantigen tumor vaccine Messenger RNA (mRNA)
Subject Toripalimab Monoclonal antibody

Indications