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

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.

Trial Details

NCT ID
NCT06496373
Phase
EARLY_PHASE1
Sponsor
Ruijin Hospital
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Fixed neoantigen tumor vaccine
  • personalized neoantigen tumor vaccine
  • PD-1 inhibitor
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment
  • Subjects must be \>/= 18 years of age at time of informed consent, regardless of gender
  • Patients who have been confirmed by pathology to have pancreatic malignant tumors and have undergone radical surgery for pancreatic malignant tumor…
  • No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by…

For full eligibility, visit ClinicalTrials.gov.

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