Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer

Last updated: November 13, 2025
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Digestive System Neoplasms

Treatment

PD-1 inhibitor

Personalized tumor preventive vaccines

Fixed neoantigen tumor vaccine

Clinical Study ID

NCT06496373
2023PCV004
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects voluntarily signed written informed consent files,Able to comply with thestudy protocol, in the investigator's judgment

  2. Subjects must be >/= 18 years of age at time of informed consent, regardless ofgender

  3. Patients who have been confirmed by pathology to have pancreatic malignant tumorsand have undergone radical surgery for pancreatic malignant tumors for 1-3 months

  4. 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

  5. Histologically confirmed pancreatic cancer samples underwent WES and RNA-seqanalyses. Bioinformatics prediction identified at least one neoantigen effectivelypresented by the patient's HLA type, including those derived from KRAS or TP53mutations.

  6. According to the investigator's assessment, the patient is unable to toleratechemotherapy, such as the score of the Eastern Cooperative Oncology Group (ECOG)Performance Scale ≥ 2 points

Exclusion

Exclusion Criteria:

  1. Has had chemotherapy, traditional Chinese medicine with antitumor indications, orother antitumor therapies deemed to conflict with the current treatment by theinvestigator within 4 weeks prior to the first administration of the study drug

  2. History of interstitial lung disease (ILD), pulmonary fibrosis

  3. Other serious and/or uncontrollable diseases, which may affect the subject'sparticipation in this study, include but not limited to a) a history of severe drugallergy, or is known to be allergic to any tumor vaccine and PD-1 inhibitorformulation components or has had severe allergic reactions to other monoclonalantibodies in the past, b) A history of immunodeficiency, including HIV positive orother acquired or congenital immunodeficiency diseases

  4. Researchers believe that there are other reasons that are not suitable forparticipating in clinical trials

Study Design

Total Participants: 20
Treatment Group(s): 4
Primary Treatment: PD-1 inhibitor
Phase: 1
Study Start date:
July 16, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200025
    China

    Active - Recruiting

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