An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma

Trial ID: NCT06156267

Interventional - Phase 1 - Not yet recruiting

This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.

Conditions

• Pancreatic Cancer

Interventions

• Adebrelimab
• mRNA tumor vaccines

Eligibility

Inclusion criteria

• Voluntarily signed the informed consent form and complied with protocols requirements.
• 2. Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
• 3. Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
• 4. Tumour specimen availability.
• 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• 6. Life expectancy ≥ 6 months.
• 7. Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.
• 8. Adequate marrow and organ function.
• 9. Patients with fertility are willing to use an adequate method of contraception.

Exclusion criteria

• Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
• 2. Unsuitable for immunotherapy assessed by the investigator.
• 3. Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment.
• 4. Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
• 5. Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
• 6. Known or highly suspected history of interstitial pneumonia.
• 7. Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
• 8. Prior malignancy within 5 years prior to study entry.
• 9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• 10. Known splenectomy history.
• 11. Concurrent severe infection within 28 days prior to initiation of study treatment.
• 12. Congenital or acquired immune deficiency.
• 13. Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
• 14. Uncontrolled or severe cardiovascular disease.
• 15. Other situations that are not suitable for inclusion in this study judged by investigator.

Sponsor

Fudan University

Source: Clinicaltrials.gov

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