Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
NCT Number: NCT06496373
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single/Fixed neoantigen mRNA vaccine includes pancreatic cancer driver mutations such as KRAS G12D, G12V, G12R, G12C, etc. Each vaccine has one neoantigen encoded by mRNA. Total of 4 cycles, 3 weeks each cycle.
personalized neoantigen tumor vaccine include 5-20 neoantigens selected based on WES/RNA-seq of patients' tumor sample during surgery. Total of 9 cycles after finishing the first 4 cycles of fixed neoantigen tumor vaccine.
Toripalimab
Time frame: 18 months
Percentage Participants with Adverse Events (AEs) by severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: Up to 18 months
Recurrence-free survival of Personalized mRNA Tumor Vaccine
Time frame: Up to 18 months
Overall Survival of Personalized mRNA Tumor Vaccine
Time frame: Up to 18 months
personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
Clinical Study of XP-004 Personlaized mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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