Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Fixed neoantigen tumor vaccine
Biological/VaccineSingle/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/Vaccinepersonalized 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
DrugToripalimab
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Neoantigen based vaccines + PD-1 inhibitorExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Drug related toxicity
Percentage Participants with Adverse Events (AEs) by severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame
18 monthsSecondary outcomes
1
Recurrence-free survival (RFS)
Recurrence-free survival of Personalized mRNA Tumor Vaccine
Time frame
Up to 18 months2
overall survival (OS)
Overall Survival of Personalized mRNA Tumor Vaccine
Time frame
Up to 18 months3
Reaction of antigen-specific T cells in peripheral blood
personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
Time frame
Up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
Shanghai Xinpu BioTechnology Company Limited
Collaborator
Source ClinicalTrials.gov