Clinical trial NCT06496373: Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Official title: Clinical Study of XP-004 Personlaized mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer Resectable
Chemotherapy-intolerant
Keywords: Personalized
Neoantigen
Pancreatic cancer
Postoperative adjuvant therapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Xinpu BioTechnology Company Limited
First posted: 2024-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 Criteria:

1. Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment
2. Subjects must be \>/= 18 years of age at time of informed consent, regardless of gender
3. 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
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. Having tumor tissue confirmed by immunohistochemistry, capable of performing WES and RNAseq sequencing, and predicted by bioinformatics analysis, it was found that there is at least one antigen in the table that has been effectively presented by self-HLA, such as KRAS or TP53 mutations and corresponding HLA subtypes
6. 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:

1. 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
2. History of interstitial lung disease (ILD), pulmonary fibrosis
3. 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
4. Researchers believe that there are other reasons that are not suitable for participating in clinical trials

Primary outcomes:
measure: Drug related toxicity
timeFrame: 18 months
Secondary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: Up to 18 months
measure: overall survival (OS)
timeFrame: Up to 18 months
measure: Reaction of antigen-specific T cells in peripheral blood
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Baiyong Shen, M.D&Ph.D
role: STUDY_DIRECTOR
References: