Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino

Inclusion criteria

• Voluntarily signed the informed consent form and complied with protocols requirements.
• Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
• Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
• Tumour specimen availability.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Life expectancy ≥ 6 months.
• Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.
• Adequate marrow and organ function.
• 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.
• Unsuitable for immunotherapy assessed by the investigator.
• 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.
• Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
• Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
• Known or highly suspected history of interstitial pneumonia.
• Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
• Prior malignancy within 5 years prior to study entry.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Known splenectomy history.
• Concurrent severe infection within 28 days prior to initiation of study treatment.
• Congenital or acquired immune deficiency.
• Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
• Uncontrolled or severe cardiovascular disease.
• Other situations that are not suitable for inclusion in this study judged by investigator.