Actively Recruiting
Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Led by Ruijin Hospital · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
S
Shanghai Xinpu BioTechnology Company Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and follow the study protocol
- Age 18 years or older at the time of consent
- Confirmed pancreatic cancer by pathology and underwent radical surgery 1-3 months ago
- No copy number variations or loss of heterozygosity in HLA-related genes by gene sequencing
- Pancreatic cancer samples analyzed by WES and RNA sequencing showing at least one neoantigen presented by patient's HLA type, including KRAS or TP53 mutations
- Assessed by investigator as unable to tolerate chemotherapy, such as ECOG Performance Scale score 2 2
You will not qualify if you...
- Received chemotherapy, antitumor traditional Chinese medicine, or other antitumor treatments within 4 weeks before first study drug dose
- History of interstitial lung disease or pulmonary fibrosis
- Severe drug allergy history or allergy to tumor vaccine or PD-1 inhibitor components, or severe allergic reactions to other monoclonal antibodies
- History of immunodeficiency including HIV or other acquired or congenital immunodeficiency diseases
- Other serious or uncontrollable diseases or conditions making study participation unsuitable as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
X
Xinjing Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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