Gastric Cancer
Conditions
Interventions
Sponsors
ZHEJIANG CANCER HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary consent to participate in the study and signed informed consent ; 2.Age 18-75 years old ( including 18 and 75 years old ) ; 3.Expected survival time = 12 weeks ; 4.ECOG physical condition 0 or 1 point ; 5.For female subjects : should be surgical sterilization, postmenopausal patients, or agree to use a medically recognized contraceptive measure ( such as intrauterine device, contraceptive pill or condom ) during the study period and within 6 months after the end of the study period ; the blood pregnancy test must be negative within 7 days prior to study administration and must be non-lactating. For male subjects : should be surgical sterilization, or agree to use a medically recognized contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period ; 6.Be able to understand the test requirements, willing and able to comply with the test and follow-up procedures. 7.Bone marrow function : Hemoglobin = 9g / dL ; absolute neutrophil count = 1.5 × 10^9 / L ; platelet count = 100 × 10^9 / L ; 8.Liver function ( based on the normal value of the clinical trial center ) : Serum total bilirubin = 1.5 times the upper limit of normal ( ULN ) ; alanine aminotransferase ( ALT ), aspartate aminotransferase ( AST ) and alkaline phosphatase ( ALP ) = 2.5 × ULN in the absence of liver metastasis, ALT, AST and ALP = 5 × ULN in the presence of liver metastasis. 9.Renal function ( based on the normal values of the clinical trial center ) : Serum creatinine = 1.5 × ULN, or creatinine clearance ( CrCl ) = 60 mL / min calculated by Cockcroft-Gault formula, or 24-hour urinary CrCl = 60 mL / min ; 10. Cardiac function : New York Heart Association ( NYHA ) grade < 3 ; left ventricular ejection fraction ( LVEF ) = 50 % ; normal QT interval, female QTc = 470ms, male QTc = 450ms. 11. Locally advanced gastric cancer ( including adenocarcinoma of the esophagogastric junction ) diagnosed histologically and / or cytologically. 12.HER2 immunohistochemistry ( IHC ) results were IHC1 +, 2 +, 3.
Exclusion criteria
Exclusion criteria: 1.Clinical research drugs were used within 4 weeks before the start of the study administration ; 2.In the study, large-scale surgery was performed within 4 weeks before the start of administration and did not fully recover ; 3.Inoculate live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ; 4.Severe arterial / venous thrombosis events, such as cerebrovascular accident ( including transient ischemic attack ), deep vein thrombosis, pulmonary embolism, myocardial infarction, etc., occurred within 1 year before the study administration ; 5.It is suffering from systemic diseases that are not under stable control, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, angina pectoris, severe arrhythmia, etc. 6.Are suffering from active infections that require systemic treatment ; 7. History of active tuberculosis ; 8.HIV test results are positive ; 9.Patients with active hepatitis B or hepatitis C ( HBsAg positive and HBV-DNA positive ; hCVAb positive ) ; 10.There is a third space effusion ( including a large amount of pleural effusion or ascites ) that cannot be controlled by drainage or other methods ; 11. It is known that some components of RC48-ADC or similar drugs have hypersensitivity or delayed-type hypersensitivity reactions ; 12. Psychiatric or substance abuse disorders that are known to have an impact on compliance with the requirements of the trial ; 13. Suffering from any other disease, metabolic disorder, abnormal physical examination or abnormal laboratory examination, according to the judgement of the researcher, there is reason to suspect that the patient has a disease or condition that is not suitable for the use of the research drug ( e.g., a woman who is pregnant or lactating or a woman / man who is preparing to give birth ), or that will affect the interpretation of the results of the study or place the patient in a high-risk situation ; 14.Estimate patients who have insufficient compliance to participate in this clinical study or who are considered by the researchers to have other factors that are not suitable for this study ; 15.Cerebral metastasis and / or cancerous meningitis ; 16.Tumor lesions have a tendency to bleed ( such as the presence of active ulcer tumor lesions and positive fecal occult blood test, a history of hematemesis or melena within 2 months before signing the informed consent form, and the risk of gastrointestinal bleeding judged by the researchers ) or received blood transfusion treatment 4 weeks before the study ; 17. Have other malignant tumors ( non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or other tumors that have been effectively treated, except for malignant tumors that are considered to have been cured ) within 5 years before signing the informed consent ; 18.Intake within 4 weeks before the start of the study administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;DFS;OS;Safety; | — |
Countries
CHINA
Contacts
Public ContactYian Du
ZHEJIANG CANCER HOSPITAL
Outcome results
None listed