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

Launched by RUIJIN HOSPITAL · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced pancreatic cancer who have recently undergone surgery and cannot tolerate traditional chemotherapy. The treatment combines a personalized mRNA vaccine, which is designed to help the body recognize and fight cancer cells, with a drug called a PD-1 inhibitor that helps boost the immune response. The main goal of the trial is to evaluate how safe and well-tolerated this combination is for patients, while also looking at how effective it might be in preventing cancer from returning and improving overall survival.

To participate in this trial, patients must be at least 18 years old, have had surgery for pancreatic cancer within the last 1 to 3 months, and be unable to tolerate chemotherapy due to their health status. Participants will receive the treatment and be monitored for any side effects and signs of effectiveness. It's important to note that certain health conditions and recent treatments may exclude patients from joining the study. This trial is currently recruiting participants, and those interested should consult with their healthcare provider to see if they qualify.

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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