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

Inclusion Criteria:

• Provision of signed and dated informed consent form;

• Aged 18 to 75 years old;

• Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;

• Completed an R0 or R1 surgical resection as determined by pathology；

• Have not received any prior neoadjuvant therapy;

• ECOG score is 0 or 1;

• Life expectancy of greater than 12 months;

• CA19-9 <100U/mL before initial chemotherapy;

• Patients must have adequate organ and marrow function defined by study-specifiedlaboratory tests prior to initial study drug.

• Woman of childbearing potential must have a negative pregnancy test and followcontraceptive guidelines as defined per protocol.

Exclusion Criteria:

• Borderline resectable pancreatic cancer;

• Evidence of disease recurrence or metastasis following surgical resection at anytime;

• Evidence of malignant ascites;

• Pre-existing inflammatory bowel disease or the presence of complete or partial bowelobstruction, or persistent severe diarrhea after surgery;

• Needs to receive long-term systemic anti-allergic drug or known hypersensitivity toany component of the study treatment;

• History of autoimmune disease;

• New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, andtransient ischemic attack) within 6 months before screening;

• Acute myocardial infarction within 6 months before screening, or uncontrolledangina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New YorkHeart Association Heart Failure Classification Criteria NYHA Class ≥ III) and othercardiovascular diseases;

• Received immunomodulatory medications within 4 weeks prior to the date of the firstdose (D1) of XH001, including but not limited to: IL-2, CTLA-4 inhibitors, CD40agonists, CD137 agonists, IFN-α;

• Received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulatingfactor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7days prior to the first dose of XH001;

• Received therapeutic tumor vaccines;

• With congenital or acquired immunodeficiency;

• Participating in other clinical trials and not enrolled at the 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 participationin this study inappropriate.