gastric hepatoid adenocarcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Histopathological diagnosed as hepatoid adenocarcinoma of the stomach; 3. According to RECIST v1.1 guidelines, at least 1 lesion, with the longest diameter 10mm, was suitable for repeated and accurate measurement; 4. ECOG PS: 0-2 points; 5. Expected survival 3 months; 6. The main organs had good functions, that is, the relevant examination indexes within 14 days before enrollment met the following requirements: (1) blood routine examination, which should meet (no blood transfusion within 14 days) : A. Hemoglobin (HB) 90g/L; B. Neutrophil (ANC) 1.5x10^9/L; C. Platelet (PLT) 80x10^9/L (2) biochemical examination shall meet the following standards: A. Total bilirubin (BIL) <1.5 times normal upper limit (ULN) B. ALT or AST<5 ULN; C. Serum Cr 1 ULN, endogenous creatinine clearance 50ml/min (Cockcroft-Gault formula) 7. Patients voluntarily participated in the study and signed the informed consent (ICF); 8. Women of child-bearing age must have a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use an appropriate method of contraception during observation and within 8 weeks after the last administration of the test drug; For men, surgical sterilization should be performed, or an appropriate method of contraception should be agreed during observation and within 8 weeks of the last administration of the experimental drug.
Exclusion criteria
Exclusion criteria: 1. Heart disease in any of the following situations: (1) Recent history of heart disease (within 6 months): acute coronary syndrome, Acute heart failure (NYHA class of ? or ?), significant ventricular arrhythmias (persistent ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation); (2) When a magnitude of ? NYHA classification or ? level in patients with heart failure; (3) The patient had severe block and permanent pacemaker failure (second - and third-degree atrioventricular block, sinus block); (4) There was an unexplained fainting within 3 months; (5) Severe uncontrolled hypertension, or symptomatic hypertension, as determined by the researchers. 2. Multiple factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction); 3. Abnormal coagulation function (INR>1.5 ULN, APTT>1.5 ULN), with bleeding tendency; 4. Any history of allergy or hypersensitivity to any of the study drugs or their excipients; 5. Pregnant or lactating women; Special attention: patients with risk of gastrointestinal bleeding were not included in the group, including the following situations: (1) active peptic ulcer lesions and fecal occult blood (++); (2) have a history of black stool or hematemesis within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FPS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS; | — |
Countries
China