Gastric cancer
Conditions
Interventions
Single arm:Low-dose apatinib combined with carilizumab and SOX
Sponsors
The First Affiliated Hospital of Nanjing Medical University /Jiangsu Provincial People's Hospital (Pukou Branch Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years (including 18 and 75 years); 2. Patients who understand the steps and contents of the study and voluntarily sign the written informed consent; 3. The clinical stage of gastric or gastroesophageal junction adenocarcinoma with HER2 negative or unknown HER2 status confirmed by histopathology and / or cytology is stage IV, which includes the tumor with clinical judgment of metastatic gastric cancer (cM1) and tumor invading adjacent organs (cT4b). Definition of potential resectability: local advanced gastric or gastroesophageal junction adenocarcinoma, swelling There was no distant metastasis or only a single distant metastasis (= 3 months; 8. For patients with good organ function, the relevant examination indexes within 14 days before admission meet the following requirements: red protein >= 90 g / L (no blood transfusion within 14 days); neutrophil count > 1.5 x 10^9 / L; platelet count >= 100 x 10^9 / L; total bilirubin = 60 ml / min (Cockcroft Gault formula); Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) >= 50%; 9. Thyroid function index: TSH and FT3 / FT4 are normal or slight and have no clinical significance; 10. The body weight is more than 40 kg (including 40 kg), or the BMI is more than 18.5.
Exclusion criteria
Exclusion criteria: 1. In the past or at the same time, patients with other malignant tumors, but the cured early tumors, including skin basal cell carcinoma and cervical carcinoma in situ, the early tumors such as stage I lung cancer and stage I colorectal cancer, after radical treatment and judged by the researchers to not affect the patient's life in a short period of time, can be excluded. 2. Patients who have participated in clinical trials of other drugs within four weeks; 3. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 4. For patients with bleeding history, any bleeding event with severe grade of 3 or more in ctcae4.0 occurred within 4 weeks before screening; 5. Before screening, patients with known or history of central nervous system metastasis were selected. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be carried out within 28 days before admission to exclude central nervous system metastasis; 6. Patients with hypertension who can not be well controlled by single antihypertensive drugs (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); patients with unstable angina; patients newly diagnosed as angina within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmias (including QTCF: male >= 450 ms, female >= 470) MS) long term use of antiarrhythmic drugs and New York Heart Association grade II or above cardiac insufficiency; 7. Patients with long-term unhealed wound or incomplete healing fracture; 8. Imaging shows that the tumor has invaded the important blood vessels or the patient's tumor may invade the important blood vessels and cause fatal bleeding during the treatment according to the researcher's judgment; 9. Patients with abnormal coagulation and bleeding tendency (14 days before randomization: INR is within the normal range without anticoagulant); patients treated with anticoagulant or vitamin K antagonists such as warfarin, heparin or their analogues; INR in prothrombin time Under the premise of 1.5, it is allowed to use low-dose warfarin (1 mg orally once a day) or low-dose aspirin (no more than 100 mg daily) for prevention purpose; 10. To screen the patients who had the event of arteriovenous thrombus in the first 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombus (except for the venous thrombus caused by the venous catheterization in the early stage of chemotherapy, which is judged to be cured by the researchers) and pulmonary embolism, etc; 11. Routine urine test indicated that urine protein was >= 0.0g and confirmed that 24-hour urine protein quantity was > 1.0g; 12. Patients who have used immunotherapy drugs; 13. Patients with a history of immune deficiency, other acquired or congenital immune deficiency diseases, or organ transplantation; 14. Patients with infectious pneumonia, noninfective pneumonia, interstitial pneumonia and other patients who need corticosteroids; 15. Patients with serious history of chronic autoimmune diseases, such as systemic lupus erythematosus, ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, irritable bowel syndrome and other chronic diarrhea diseases, sarcoidosis or tuberculosis, active hepatitis B, hepatitis C and HIV infection, well controlled non serious immune diseases, such as dermatitis , arthritis, psoriasis, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;DOR;R0/R1;MPR; | — |
Countries
China
Contacts
Public ContactXiaofeng Chen
Jiangsu People's Hospital
Outcome results
None listed