A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients

Exclusion Criteria

• •If a subject meets any of the following conditions, they will not be allowed to enter this study
• •* Patients with allergies or suspected allergies to research drugs or similar drugs;
• •* Suffering from other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
• •* Received live vaccine within 4 weeks prior to enrollment or possibly during the study period;
• •* Suffering from active autoimmune diseases or having a history of autoimmune diseases within 4 weeks prior to enrollment;
• •* Previously received allogeneic bone marrow transplantation or organ transplantation;
• •* The patient currently has any disease or condition that affects drug absorption, or the patient is unable to take medication orally;
• •* The patient currently has hypertension that cannot be controlled by medication, which is defined as: patients with hypertension who cannot be well controlled with a single antihypertensive drug treatment #systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100mmHg#; Or use two or more antihypertensive drugs to control blood pressure in patients;
• •* Urinary routine indicates that urine protein is ≥ 2+, and the 24-hour urine protein volume is\>1.0g;
• •* The patient currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;
• •* Patients with significant evidence of bleeding tendency or medical history within the 3 months prior to enrollment #bleeding\>30 mL within 3 months, vomiting blood, black stool, and rectal bleeding#, hemoptysis #fresh blood\>5 mL within 4 weeks#, or thromboembolic events #including stroke events and/or transient ischemic attacks# within 12 months;
• •* Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting surgery within 6 months prior to enrollment; Congestive heart failure is classified by the New York Heart Association #NYHA# as\>level 2; Ventricular arrhythmia requiring medication treatment; Electrocardiogram #ECG# shows a QT interval of ≥ 480 milliseconds;
• •* Active or uncontrolled severe infection #≥ CTCAE level 2 infection#;
• •* Known human immunodeficiency virus #HIV# infection; Known clinically significant history of liver disease, including viral hepatitis \[known carriers of hepatitis B virus #HBV# must exclude active HBV infection, i.e. HBV DNA positivity #\>1 × 104 copies/mL or\>2000 IU/ml#; Known hepatitis C virus infection #HCV# and HCV RNA positivity #\>1 × 103 copies/mL, or other types of hepatitis or cirrhosis;
• •* According to the judgment of the researchers, patients deemed unsuitable for inclusion in this study.