Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Recruiting · NCT06496373 · Interventional (participants receive a specific treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 tumors for 1-3 months
- No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by gene sequencing
- Histologically confirmed pancreatic cancer samples underwent WES and RNA-seq analyses. Bioinformatics prediction identified at least one neoantigen effectively presented by the patient's HLA type, including those derived from KRAS or TP53 mutations.
- According to the investigator's assessment, the patient is unable to tolerate chemotherapy, such as the score of the Eastern Cooperative Oncology Group (ECOG) Performance Scale ≥ 2 points
Exclusion criteria
- Has had chemotherapy, traditional Chinese medicine with antitumor indications, or other antitumor therapies deemed to conflict with the current treatment by the investigator within 4 weeks prior to the first administration of the study drug
- History of interstitial lung disease (ILD), pulmonary fibrosis
- Other serious and/or uncontrollable diseases, which may affect the subject's participation in this study, include but not limited to a) a history of severe drug allergy, or is known to be allergic to any tumor vaccine and PD-1 inhibitor formulation components or has had severe allergic reactions to other monoclonal antibodies in the past, b) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases
- Researchers believe that there are other reasons that are not suitable for participating in clinical trials
Where it is running
1 location listed.
- Ruijin Hospital Shanghai Jiaotong University School of Medicine - Shanghai, Shanghai Municipality, China