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NCT Number: NCT06496373

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Baiyong Shen, Ph.D&M.D

CONTACT

0086-021-64370045

Baiyong Shen, Ph.D&M.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed neoantigen tumor vaccine

Biological

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.

Personalized neoantigen tumor vaccine

Biological

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.

PD-1 inhibitor

Drug

Toripalimab

Primary outcomes

  1. Drug related toxicity

    Time frame: 18 months

    Percentage Participants with Adverse Events (AEs) by severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Secondary outcomes

  1. Recurrence-free survival (RFS)

    Time frame: Up to 18 months

    Recurrence-free survival of Personalized mRNA Tumor Vaccine

  2. overall survival (OS)

    Time frame: Up to 18 months

    Overall Survival of Personalized mRNA Tumor Vaccine

  3. Reaction of antigen-specific T cells in peripheral blood

    Time frame: Up to 18 months

    personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses

Study contacts

Contact information is provided by the study sponsor or research team.

Xinjing Wang

CONTACT

[email protected]

18817821319

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai Xinpu BioTechnology Company Limited

Registry information

Official study title

Clinical Study of XP-004 Personlaized mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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