A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer

Exclusion Criteria

• •1. Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
• •2. Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
• •3. Patients with known germ line BRAC1/2 mutation.
• •4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
• •5. Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
• •6. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors.
• •7. Major surgery other than the diagnosis of pancreatic cancer within 28 days prior to the first dose or major surgery is expected during the study.
• •8. Pregnant or lactating women.
• •9. Patients who received any prior treatments targeting the mechanism of tumor immunity.
• •10. Patients with known contraindications to prescribed chemotherapy regimen (see instructions for specific drug).
• •11. Patients with known medical history of severe hypersensitivity reactions to other monoclonal antibodies or intravenous gamma globulin.
• •12. Active autoimmune disease within 2 years prior to the start of study treatmen.
• •13. Known active pulmonary tuberculosis.
• •14. Patients with active hepatitis B or active hepatitis C.
• •15. Known medical history of immunodeficiency or positive HIV test.
• •16. Patients with active infection.
• •17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• •18. Concurrent participation in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.
• •19. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug, or would interfere with the evaluation of the study drug or the safety of patients, or the interpretation of the study results.