XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer

Exclusion Criteria

• •Borderline resectable pancreatic cancer;
• •Evidence of disease recurrence or metastasis following surgical resection at any time;
• •Evidence of malignant ascites;
• •Pre-existing inflammatory bowel disease or the presence of complete or partial bowel obstruction, or persistent severe diarrhea after surgery;
• •Needs to receive long-term systemic anti-allergic drug or known hypersensitivity to any component of the study treatment;
• •History of autoimmune disease;
• •New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening;
• •Acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases;
• •Received immunomodulatory medications within 4 weeks prior to the date of the first dose (D1) of XH001, including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α;
• •Received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days prior to the first dose of XH001;
• •Received therapeutic tumor vaccines;
• •With congenital or acquired immunodeficiency;
• •Participating in other clinical trials and had not withdrawn during screening period;
• •Unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator;
• •Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.