mRNA vaccine and PD-1 inhibitor for pancreatic cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and tolerability of a personalized mRNA vaccine combined with a PD-1 inhibitor as adjuvant therapy for patients with resectable pancreatic cancer who cannot tolerate chemotherapy. The study aims to assess the immune response through T cell activation and monitor recurrence-free and overall survival rates in participants following radical surgery. The approach utilizes neoantigens derived from the patient's tumor to tailor the vaccine specifically to their cancer profile.

Why it matters

Who can join: the full rules

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. 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.
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

Where it's running

• Ruijin Hospital Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xinjing Wang
• Email: newvista89@163.com
• Phone: 18817821319

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Nimotuzumab with nab-paclitaxel and gemcitabine for EGFR-positive pancreatic cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.