Gastric cancer
Conditions
Interventions
1:Initomab combined with XELOX
2:Initolumab combined with pyrrotinib + paclitaxel
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Understand the test procedures and content, and voluntarily sign written informed consent; 2) Aged 18-80 years; 3) Patients with HER2+ gastric or gastroesophageal junction adenocarcinoma diagnosed pathologically, with locally advanced stage or distant metastases that are not resectable; 4) HER2 positive definition: including IHC +++ or ISH positive; IHC ++, should be further carried out by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH), silver enhanced in situ hybridization (SISH) and other methods HER2 gene amplification test. The test report can be issued by a qualified laboratory and verified by the clinical research center where the subject is located; 5) Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) 0-1; 6) Expected survival period >= 12 weeks; 7) There are measurable target lesions (according to the RECIST 1.1 standard, the CT scan of tumor lesions has a long diameter >= 10 mm, and a CT scan of lymph node lesions has a short diameter >= 10 mm); 8) Have not used trastuzumab, initumumab, pyrrotinib and other anti-HER2 targeted drugs in the past, use other cytotoxic drugs, you need to stop at least 4 weeks before entering the group; 9) Baseline (28 days before randomization) left ventricular ejection fraction (LVEF) >= 50%; 10) Except for the primary disease, no serious hematology, liver, kidney and other diseases. Requirements: a) Absolute neutrophil count (ANC) >= 1.5*10^9/L [without using granulocyte/granulocyte-macrophage colony stimulating factor (G-CSF/GM-CSF) or other medical support therapies]; Platelets >= 100*10^9/L; Hemoglobin >= 90g/L (without blood transfusion or using blood cytokines and other medical supportive therapies within 14 days); b) Serum creatinine = 50ml/min; c) Serum total bilirubin (STB) 1.0 ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 2.5* ULN (ALT or AST <= 5 * ULN is acceptable for liver metastases); d) International normalized ratio (INR) <= 1.5, and activated partial prothrombin time (aPTT) <= 1.5 * ULN (unless anticoagulant therapy is also received).
Exclusion criteria
Exclusion criteria: 1) Suffer from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease; 2) Pregnant or lactating women; 3) Participate in another clinical trial within 28 days prior to screening (if it is a monoclonal antibody trial, within 5 half-lives of the drug), have received active drug treatment, or intend to participate in another clinical trial during the entire study period; 4) There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 5) Those who have undergone major surgery or severe trauma within 28 days before screening, or are expected to undergo major surgery during the trial period (defined as surgery that requires more than 3 weeks in the recovery period after surgery); 6) There is a large amount of serous effusion (including chest and abdominal cavity, pericardial cavity); 7) Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening; 8) A history of arterial thrombosis or deep venous thrombosis within 6 months before screening, or any bleeding event with a severe grade of CTCAE 4.0 or higher in the 4 weeks before screening; fecal occult blood is positive, confirmed by gastroscopy to be active Bleeding; 9) There is a clinically significant active infection that requires systemic treatment (NCI CTCAE> level 2); 10) Existence of systemic severe or uncontrolled underlying diseases (including breathing difficulties or severe lung disease at rest, metabolic diseases, abnormal wound healing, ulcers or fractures, abnormal blood clotting, mental disorders or recent use of psychotropic drugs, immunodeficiency Or the history of organ transplantation, etc.) or abnormal laboratory examinations, the investigator believes that it will significantly increase the risk of trial drug administration, or affect the evaluation of efficacy; 11) Uncontrolled hypertension (systolic blood pressure >= 140mmHg and/or diastolic blood pressure >= 90mmHg) or pulmonary hypertension or unstable angina, a history of chronic heart failure or left ventricular hypertrophy that meets the standards of the New York Heart Association (NYHA), with Clinical significance of valvular disease, severe arrhythmia that requires treatment (except for atrial fibrillation, paroxysmal supraventricular tachycardia) or clinically significant conduction abnormalities visible on the electrocardiogram; history of myocardial infarction within 6 months before screening; During or after neoadjuvant or adjuvant trastuzumab treatment, heart failure occurred or LVEF dropped below 50%; 12) Non-hematological toxicity caused by previous treatments is >= Grade 1 before screening (CTCAE 5.0, except for neurotoxicity = 1*10^3 copies/mL or local laboratory method> lower limit of quantification; if HBV-DNA titer test < 1*10^3 copies/mL or local laboratory method <= lower limit of quantification, if the investigator judges that the subject's chronic hepatitis B is in a stable phase and will not increase the risk of the subject, they can be included in the group; 15) Known allergic re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactJing Liang
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed