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NCT06496373RecruitingEarly phase 1

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

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

Source: ClinicalTrials.gov · Last updated 17 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
20 (estimated)
First submitted
18 Jun 2024
Start date
16 Jul 2024
Primary completion date
30 Jun 2026
Lead sponsor
Ruijin Hospital
NCT number
NCT06496373

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 20
  • From 16 Jul 2024 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Researchers believe that there are other reasons that are not suitable for participating in clinical trials

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.