Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fixed neoantigen tumor vaccine, personalized neoantigen tumor vaccine, PD-1 inhibitor.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer Resectable, Chemotherapy-intolerant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study of XP-004 Personlaized mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Overview
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.
Interventions
- Biological Fixed neoantigen tumor vaccine
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. - Biological personalized neoantigen tumor vaccine
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. - Drug PD-1 inhibitor
Toripalimab
Primary outcome measures
- Drug related toxicity [Time frame: 18 months]
Secondary outcome measures (3)
- Recurrence-free survival (RFS) [Time frame: Up to 18 months]
- overall survival (OS) [Time frame: Up to 18 months]
- Reaction of antigen-specific T cells in peripheral blood [Time frame: Up to 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT06496373 · 2023PCV004