Actively Recruiting
Clinical Study of XP-004 Personalized 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
52 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
Researchers are evaluating the safety and tolerability of XP-004 personalized mRNA vaccines combined with a PD-1 inhibitor as additional therapy for patients who have had radical surgery for pancreatic cancer but cannot tolerate chemotherapy. This early phase 1 study also aims to explore preliminary effectiveness by measuring immune response, recurrence-free survival, and overall survival in these patients after surgery. Participants receive a sequence of treatments starting with four cycles of single or fixed target mRNA vaccines targeting common pancreatic cancer mutations, followed by nine cycles of personalized mRNA vaccines tailored to each patient's tumor mutations. These vaccines are given alongside a PD-1 inhibitor called Toripalimab every three weeks, totaling 13 treatment cycles. During the study, participants will be closely monitored for drug-related side effects over 18 months. Researchers will assess immune responses by measuring specific T cell activation in the blood and track how long patients remain free from cancer recurrence as well as overall survival. The study involves regular visits for treatment administration, blood tests, and evaluations to understand safety and potential benefits of this combination therapy after pancreatic cancer surgery.
CONDITIONS
Brief 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...
- Signed informed consent and able to follow study protocol
- 18 years of age or older
- Pathologically confirmed pancreatic cancer and underwent radical surgery 1 to 3 months prior
- No copy number variations or loss of heterozygosity in HLA-related genes by gene sequencing
- Tumor samples analyzed to identify 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 status 2 or higher
You will not qualify if you...
- Received chemotherapy, antitumor traditional Chinese medicine, or other conflicting antitumor therapies within 4 weeks before first study drug dose
- History of interstitial lung disease or pulmonary fibrosis
- Serious uncontrolled diseases including severe drug allergy, allergy to tumor vaccine or PD-1 inhibitor components, or history of immunodeficiency such as HIV
- Any other reasons making participation unsuitable as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 39 weeks
Participants receive a sequential treatment starting with 4 cycles of fixed neoantigen mRNA vaccines every 3 weeks, followed by 9 cycles of personalized neoantigen mRNA vaccines, combined with PD-1 inhibitor treatment every 3 weeks, totaling 13 cycles.
Visits every 3 weeks for 13 cycles (in-person)
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
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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