drugset / Trial / NCT06496373
Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Phase 0
Recruiting
20 enrolled
Ruijin Hospital
Shanghai Xinpu BioTechnology Company Limited · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fixed neoantigen tumor vaccine | Messenger RNA (mRNA) | — | — |
| Subject | Personalized neoantigen tumor vaccine | Messenger RNA (mRNA) | — | — |
| Subject | Toripalimab | Monoclonal antibody | — | — |