gastric cancer
Conditions
Interventions
experimental group:Inetuzumab
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by pathology who are not surgically resectable and have locally advanced disease or distant metastasis; 3. HER2-positive definition: Fluorescence in situ hybridization (FISH) positive (+) and immunohistochemistry (IHC) result of 2+, or IHC 3+; the test report is acceptable if issued by a qualified laboratory and verified by the clinical research center where the subject is located. 4. ECOG PS: 0 to 2 points; expected survival time >= 3 months; 5. No prior use of anti-HER2 targeted drugs such as trastuzumab and inotuzumab. If other cytotoxic drugs or traditional Chinese medicine for anti-tumor treatment have been used, they must be discontinued for at least 4 weeks before enrollment. 6. At least one target lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and this target lesion has not received radiotherapy (or other local treatment), unless progression occurred after completion of such treatment (RECIST 1.1 criteria, see Appendix 2); 7. The main organs and bone marrow function are basically normal (no use of any blood components, blood products, or cell growth factors is allowed within 2 weeks before the study treatment): 1) Complete blood count: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, Hemoglobin >= 90g/L; 2) International Normalized Ratio (INR) = 60 mL/min (see Appendix 5); 5) Normal cardiac function, with Left Ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography >= 50%. 8. Fully understands this study, voluntarily participates, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously treated with immune checkpoint inhibitors; 2. ECOG performance status > 2, or expected survival time = 2 grade); 8. Active, known, or suspected autoimmune diseases; however, patients with vitiligo who did not require systemic treatment within 2 years prior to the first dose of the study drug are allowed to enroll; patients with hypothyroidism requiring only thyroid hormone replacement, patients with type 1 diabetes requiring only insulin replacement, and patients with hypophysitis or adrenal insufficiency requiring only physiological hormone replacement are also eligible for enrollment. 9. Has a history of HIV infection, or has an active bacterial or fungal infection requiring systemic treatment within 14 days prior to the first administration of the study drug; 10. A history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease, or active pneumonia detected on chest CT scan within 4 weeks prior to the first dose of the study drug. 11. During the screening period, accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, etc.; 12. During the screening period, HBV DNA must be =2000 IU/ml (or =10^4 copies/ml), and participants must have their HBV DNA reduced to 2000 IU/ml (or 10^4 copies/ml) using entecavir before being enrolled. Note: For participants enrolled with Anti-HBc(+)/HBsAg(+)/HBV DNA 2000 IU/ml or Anti-HBc(+)/HBsAg(-)/HBV DNA 2000 IU/ml, antiviral treatment must be administered concurrently during the trial, which can be the original medication or entecavir. For participants enrolled with HCV RNA positivity, the investigator will decide whether to administer concurrent antiviral treatment. 13. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurring within 6 months prior to enrollment, congestive heart failure (New York Heart Association class >=2, see Appendix 3); arrhythmias requiring treatment with antiarrhythmic drugs other than beta-blockers or digoxin; repeated electrocardiogram detection of QTcF interval >450 milliseconds (ms); hypertension that is not well controlled despite antihypertensive medication (systolic blood pressure >150 mmHg, diastolic blood pressure >100 mmHg); 14. There is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Response Rate;Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactLiQian
HenanCancerHospital
Outcome results
None listed