gastric cancer
Conditions
Interventions
therapeutic group:surufatinib combined with standard chemotherapy
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18~75 years old; 2. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 to 1; 3. Patients with HER2-negative advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have failed with first-line standard systemic therapy; 4. At least one measurable lesion that meets the requirements of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; if the lesion that has received local therapy (radiotherapy, ablation, vascular intervention, etc.) in the past is the only lesion, the lesion must have disease Clear imaging evidence of progression; 5. Expected survival period >= 6 months; 6. Laboratory test results within 7 days prior to first receiving study drug must meet the following criteria: (1) Neutrophil count >= 1.5 x109/L, platelet count >= 100 x 10^9/L, hemoglobin >= 80 g/L; (2) Serum total bilirubin = 50 mL/min (calculated according to Cockcroft-Gault formula); (5) Urine routine examination shows urine protein = 2+, 24-hour urine protein quantitative should be <1 g; (6) International normalized ratio (INR) <=1.5 and partial activated prothrombin time (APTT) <= 1.5 x ULN. 7. Female patients of childbearing age or male patients whose partners are females of childbearing age should take effective contraceptive measures from at least 1 month before the first dose of the study drug to 6 months after the last dose of the study drug. 8. Fully understand this research and sign the informed consent voluntarily;
Exclusion criteria
Exclusion criteria: 1. The toxicity of previous anti-tumor therapy has not recovered 30 mL within 2 months, hematemesis, melena, blood in the stool), hemoptysis (>5 mL fresh blood within 4 weeks) blood); 9. Arterial thrombosis or deep vein thrombosis occurred within 6 months before first receiving study drug; or thromboembolic event (including stroke event and/or transient ischemic attack) occurred within 12 months; 10. Suffering from active pulmonary tuberculosis, receiving anti-tuberculosis treatment or receiving anti-tuberculosis treatment within 1 year before first receiving the study drug; 11. Patients with past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc. that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; radiation therapy is allowed Radiation pneumonitis in the region; 12. There are currently corneal lesions diagnosed by ophthalmological examination, including but not limited to bullous keratopathy, band-shaped corneal degeneration, corneal abrasion, corneal ulcer, keratitis, etc.; 13. Known history of clinically significant liver disease, including active viral hepatitis infection (HBV surface antigen HBsAg) and/or hepatitis B core antibody (HBcAb) positive, hepatitis B virus (HBV) DNA > 1 x 10^3 copies/mL or >2000 IU/mL; known hepatitis C virus (HCV) antibody positive and HCV RNA >1 x 10^3 copies/mL], or other hepatitis, clinically significant moderate to severe liver cirrhosis; 14. Human immunodeficiency virus (HIV) antibody positive; 15. Severe cardiovascular disease, including: (1) Various clinically significant arrhythmias or conduction abnormalities requiring clinical intervention; (2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactXiuying Xiao
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed