- Any active autoimmune disease or history of autoimmunity (as follows, but not limited
to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis,
hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism; Subjects with
vitiligo or asthma in childhood have been completely relieved and do not need any
intervention after adulthood can be included; Asthma in which subjects need
bronchodilators for medical intervention cannot be included).
- Those who have used other drugs in clinical trials within 4 weeks before the first
medication.
- Severe allergic reaction to monoclonal antibody.
- The number of neutrophils in peripheral blood was less than 1500 / mm3.
- There are cardiac clinical symptoms or diseases that are not well controlled.
- Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular
targeted therapy.
- The subjects were innate or acquired immunodeficiency (such as HIV), or active
hepatitis (hepatitis B reference: HBsAg) positive, HBVDNA > 2000IU/ml or copy number >
104/ml; Hepatitis C reference: HCV antibody positive.
- According to the judgment of the researcher, the subject has other factors that may
lead to the forced midway termination of this study, such as other serious diseases
(including mental diseases) requiring combined treatment, serious laboratory
abnormalities, accompanied by family or social factors, which will affect the safety
of the subject, or the collection of data and samples.
- The researchers judged the patients with high risk of esophageal perforation or no
potential possibility of surgery through endoscopic ultrasonography or imaging.