gastric cancer
Conditions
Interventions
Treatment group:Irinotecan liposome combined with apatinib treatment
Sponsors
The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Advanced gastric adenocarcinoma (gastric adenocarcinoma and gastroesophageal junction adenocarcinoma) diagnosed by pathology, with measurable lesions outside the stomach (spiral CT scan >= 10mm, meeting RECIST 1.1 criteria); 2. Age: 18-75 years old; 3. Late stage gastric cancer patients who have failed first-line chemotherapy (definition of treatment failure: intolerable toxic side effects, disease progression during treatment, or recurrence after treatment) 4. HER2 negative and HER2 positive patients who have previously received trastuzumab treatment 5. ECOG PS score: 0-1 point; 6. Life expectancy >= 12 weeks; 7. The main organ functions well, meeting the following criteria a. Neutrophils >= 2 × 10^9/L; b. White blood cell count >= 3.0 × 10^9/L; c. Platelets >= 100 × 10^9/L; d. Hemoglobin >= 90 g/L; e. Total bilirubin = 50 ml/min or blood creatinine = 50%. 8. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Unable to understand the nature of the research or without obtaining informed consent; 3. Merge other primary tumor patients; 4. Received any other clinical investigational drug treatment within the first 4 weeks of randomization, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up; 5. Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1); 6. Occurrence of heart disease within the first 3 months of screening, including grade 3/4 congestive heart failure, arrhythmias requiring medication or myocardial infarction, arrhythmias known to increase the risk of thrombotic events (such as atrial fibrillation), or subjects with prolonged corrected QT interval (QTc); 7. Individuals with hypertension who cannot be reduced to the normal range through antihypertensive medication (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg), those with grade I or above coronary heart disease, grade I arrhythmia (including QTc interval prolongation>450 ms in males and>470 ms in females), and grade I cardiac dysfunction; Patients with positive urinary protein; 8. Serious abnormalities in coagulation function, bleeding tendency, or currently undergoing thrombolytic or anticoagulant therapy. Allow the prophylactic use of low-dose aspirin (= 500 IU/mL or 2500 copies/mL), hepatitis C (hepatitis C antibody positive and HCVRNA higher than the upper limit of normal value); 13. Known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection; 14. Having a clear history of neurological or mental disorders, including epilepsy or dementia; 15. Researchers determine other situations that are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Overall survival;The levels of CA125, CEA, CA153, and CA724;Adverse event; | — |
Countries
China
Contacts
Public ContactYin Xiaoran
The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Outcome results
None listed