Locally advanced adenocarcinoma of the gastroesophageal junction
Conditions
Interventions
Experimental group:Apatinib + Carrelizumab + Oxaliplatin + Tegafur, three-week course
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects aged 18 to 75 years (including 18 years old and 75 years old); 2.Understand the research procedures and content, and voluntarily sign a written informed consent form; 3.Adenocarcinoma of the stomach or gastroesophageal junction with HER2-negative or unknown HER2 status confirmed by histopathology and/or cytology. The clinical stage is T3-4/N+ by imaging evaluation such as endoscopy and CT/MRI. M0 patients with locally advanced gastric cancer; 4.Physical fitness score (ECOG PS score): 0-1 points; 5.The expected survival period is >=3 months; 6.The main organs function well, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements: hemoglobin >= 80 g/L (without blood transfusion within 14 days); Neutrophil count> 1.5x10^9/L; Platelet count >= 100 x10^9/L; Total bilirubin = 60 mL/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 7.Thyroid function indicators: Thyroid-stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range or slight abnormalities with no clinical significance; 8.Body weight above 40 kg (including 40 kg), or BMI> 18.5.
Exclusion criteria
Exclusion criteria: 1.Early-stage tumors that have suffered from other malignant tumors in the past or at the same time but have been cured, including skin basal cell carcinoma and cervical carcinoma in situ, stage I lung cancer, stage I colorectal cancer and other early stage tumors are judged by the investigator after radical treatment Tumors that do not affect the life of the patient in the short term can be excluded; 2.Participated in other drug clinical trials within four weeks; 3.There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 4.There is a history of bleeding, and any serious bleeding event of degree 3 or above in the CTCAE 5.0 standard occurred within 4 weeks before screening; 5.Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to exclude central nervous system metastases; 6.Patients with high blood pressure who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); A history of unstable angina pectoris; Patients who were newly diagnosed with angina pectoris within 3 months before screening or had myocardial infarction within 6 months before screening; Arrhythmias (including QTcF: male >=450 ms, female >=470 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association classification >= Class II cardiac insufficiency; 7.Long-term unhealed wounds or fractures with incomplete healing; 8.Imaging shows that the tumor has invaded the periphery of important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels and cause fatal bleeding during treatment; 9.Abnormal coagulation function and bleeding tendency (14 days before randomization must meet: INR is within the normal range without using anticoagulants); Use anticoagulants or vitamin K antagonists such as warfarin, Patients treated with heparin or its analogues; Under the premise that the prothrombin time international normalized ratio (INR) =++ and the 24-hour urine protein quantity is confirmed to be >1.0 g; 12.Have used immune targeted therapy drugs; 13.Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 14.Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need to use corticosteroids; 15.Have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus; have a history of ulcerative enteritis, Crohns disease and other inflammatory bowel diseases, have a history of chronic diarrheal diseases such as irritable bowel syndrome; A history of tuberculosis o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Negative margin resection rate under microscope;Disease-free survival time;Overall survival time; | — |
Countries
China
Contacts
Public ContactChen Xiaofeng
Jiangsu Province Hospital
Outcome results
None listed