mRNA vaccine and PD-1 inhibitor for pancreatic cancer treatment
Clinical Study of XP-004 Personlaized mRNA Vaccine Combined With PD-1 Inhibitor as Adjuvant Therapy for Postoperative Pancreatic Cancer
This study is testing a personalized mRNA vaccine combined with a PD-1 inhibitor to see if it can help people with resectable pancreatic cancer who can’t tolerate chemotherapy after their surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06496373 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone radical surgery for pancreatic cancer and cannot tolerate chemotherapy.
Not a fit: Patients with pancreatic cancer who are able to tolerate chemotherapy or those with significant comorbidities that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, personalized therapeutic option for patients with pancreatic cancer who are unable to undergo chemotherapy.
How similar studies have performed: While the combination of mRNA vaccines and PD-1 inhibitors is a novel approach, similar immunotherapy strategies have shown promise in other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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. 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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.