Status:
RECRUITING
Clinical Study of mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Shanghai Xinpu BioTechnology Company Limited
Conditions:
Pancreatic Cancer Resectable
Chemotherapy-intolerant
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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-intole...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06496373
Start Date
July 16 2024
End Date
June 30 2027
Last Update
November 17 2025
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025