Phase
Condition
Digestive System Neoplasms
Treatment
PD-1 inhibitor
Personalized tumor preventive vaccines
Fixed neoantigen tumor vaccine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects voluntarily signed written informed consent files,Able to comply with thestudy protocol, in the investigator's judgment
Subjects must be >/= 18 years of age at time of informed consent, regardless ofgender
Patients who have been confirmed by pathology to have pancreatic malignant tumorsand 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-seqanalyses. Bioinformatics prediction identified at least one neoantigen effectivelypresented by the patient's HLA type, including those derived from KRAS or TP53mutations.
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:
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
History of interstitial lung disease (ILD), pulmonary fibrosis
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
Researchers believe that there are other reasons that are not suitable forparticipating in clinical trials
Study Design
Connect with a study center
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200025
ChinaSite Not Available
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai 1796236, Shanghai Municipality 1796231 200025
ChinaActive - Recruiting

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