A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer

Who cannot join

• 1. Previous treatment with PD-1/PD-L1 antibodies, cytotoxic T lymphocyte-associated antigen-4 antibodies, or other PD-1/PD-L1 inhibitors; 2. Past hypersensitivity to monoclonal antibodies and inactive ingredients of this product; 3. Previous use of immunosuppressive drugs within 14 days prior to the first dose of study drug, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroid hormones (i.e., up to 10 mg/day of prednisolone or pharmacophysiologically equivalent doses of other corticosteroids).； 4. Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study; 5. Patients with clinical signs and symptoms of central nervous system metastasis or other evidence that central nervous system metastasis has not been controlled are not suitable for inclusion according to the judgment of the investigator, and those with meningeal metastasis history or symptoms and signs need to be excluded; 6. Toxicity of previous antineoplastic therapy did not recover to the level of CTCAE v5.0 ≤ 1 or the level specified in the inclusion/exclusion criteria; except for other toxicities such as alopecia, which the investigator considered did not pose a safety risk to the patient; 7. Advanced patients with symptoms, dissemination to the viscera, and risk of life-threatening complications in the short term (including patients with uncontrollable massive exudates [thoracic, pericardial, abdominal], pulmonary lymphangitis, and liver involvement of more than 30%); 8. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis,Hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring medical intervention of bronchodilators can not be included); 9. Any other malignancy diagnosed within 3 years prior to study entry, except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and hepatitis C virus-RNA above the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C; 11.Myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac dysfunction, and poorly controlled arrhythmias (including Corrected QT Interval interval > 450 ms in men and > 470 ms in women) within 6 months prior to study entry. QTcF interval was calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 12.Hypertension that is not well controlled by antihypertensive medication (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg); 13. Coagulation dysfunction (INR > 1.5 or APTT > 1.5 × ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 14. Known hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc; 15. Patients with obvious hemoptysis or daily hemoptysis volume of half a teaspoon (2.5 ml) or more within 2 months before entering the study; 16. There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before entering the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + and above, or vasculitis; 17. Arterial/venous thrombotic events occurred within 6 months before entering the study, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism.
• 18. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 19. Long-term anticoagulation therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day); 20. Complicated with severe infection within 4 weeks before the first medication (e.g., need for intravenous antibiotics, antifungal or antiviral drug), or unexplained fever > 38.5 ° C during screening/before first dose; 21. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 22. Participated in any other clinical study of the drug within 4 weeks prior to the first dose, or not more than 5 half-lives from the last study dose; 23. Known history of psychotropic substance abuse or drug use; 24. Patients with other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the results of the study, and who are not considered suitable for participation in the study by the investigator.