Locally advanced adenocarcinoma of the stomach and gastroesophageal junction
Conditions
Interventions
Experimental group:Nivolumab combined with chemotherapy
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Understand the test steps and content, and voluntarily sign a written informed consent; 2. Aged 18 to 75 years; 3. Patients with gastric or gastroesophageal junction adenocarcinoma diagnosed by endoscopy and pathology, HER2 negative, clinical stage cT3-4N+M0; 4. Eastern Cooperative Oncology Group (ECOG) physical status (PS) 0-1 points; 5. Have not received neoadjuvant/adjuvant therapy related to gastric or gastroesophageal junction adenocarcinoma before; 6. In addition to the primary disease, there is no serious hematology, liver, kidney and other diseases. Requirements: (1) Absolute neutrophil count (ANC) >= 1.5x10^9/L; platelets >= 100 x 10^9/L; hemoglobin >= 90g/L (with no blood transfusion or medical supportive therapy such as blood cytokines within 14 days) case); (2) Serum creatinine = 50 mL/min; (3) Serum total bilirubin (STB)1.0 ULN in patients with Gilbert syndrome); aspartate aminotransferase (AST) or alanine aminotransferase (ALT)<=2.5 x ULN (for liver metastases, ALT or AST <= 5 x ULN is acceptable); (4) International normalized ratio (INR) <= 1.5, and activated partial prothrombin time (aPTT) <= 1.5 x ULN (unless concurrently receiving anticoagulation therapy).
Exclusion criteria
Exclusion criteria: 1. Suffering from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease; 2. Participate in another clinical study within 28 days before screening (in the case of a monoclonal antibody test, within 5 half-lives of the drug), have received active drug treatment, or intend to participate in another clinical study throughout the study period; 3. Radiotherapy within 2 weeks before screening; 4. Those who have undergone major surgery or serious trauma within 28 days before screening or are expected to require major surgery during treatment (defined as surgery requiring more than 3 weeks of recovery after surgery); 5. There is a clinically significant active infection requiring systemic treatment (NCI CTCAE>2); 6. There are systemic severe or uncontrolled underlying diseases (including dyspnea or severe lung disease at rest, metabolic diseases, abnormal wound healing, ulcers or fractures, etc.) or abnormal laboratory tests, which the investigator believes will significantly increase the experimental drug Dosing risks, which may affect the evaluation of efficacy; 7. Uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg) or pulmonary hypertension or unstable angina, history of chronic heart failure or left ventricular hypertrophy meeting New York Heart Association (NYHA) criteria , clinically significant valve disease, severe arrhythmias requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), or clinically significant conduction abnormalities seen on ECG; history of myocardial infarction within 6 months prior to randomization ; a heart failure event or a LVEF drop below 50% during or after prior neoadjuvant or adjuvant trastuzumab therapy; 8. Non-hematological toxicity caused by previous treatment is >= 1 grade before randomization (CTCAE 5.0, except for neurotoxicity of = 1 x 10^3 copies/mL or local laboratory methods> Quantitative lower limit; if HBV-DNA drops Quantitative detection 10 mg/day); 12. Those who are known to have a history of allergic reactions to experimental drugs such as nivolumab and oxaliplatin, or murine or human proteins or any of their excipients, known to have a history of allergic diseases or allergic reactions physique; 13. The researcher believes that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pCR rate; | — |
Countries
China
Contacts
Public ContactLiang Jing
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed