Gastroesophageal cancer
Conditions
Interventions
experimental group:fruquintinib combined with SOX regimen
Sponsors
Linyi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily sign the informed consent for this study; 2. Age 18-75 years old (including 18 and 75 years old); 3. Pathologically resectable or potentially resectable locally advanced gastroesophageal junction adenocarcinoma (cT3/4aN+M0); 4. If bone metastasis is suspected, bone scan should be performed. If peritoneal metastasis is suspected, laparoscopy should be performed. 5.ECOG performance status 0-1 with no deterioration within 7 days; 6.BMI=18; 7. Expected survival =12 months; 8. Have not received any anti-tumor therapy (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 9. At least one measurable lesion (meeting RECIST 1.1 criteria); 10. Vital organ function meets the following requirements (no use of blood components and cell growth factors within 14 days before enrollment) : ? Absolute neutrophil count =1.5×109/L and white blood cell =4.0×109/L; ? Platelets =100×109/L; ? Hemoglobin =90g/L; ? Total bilirubin TBIL=1.5 times ULN; ?ALT and AST=2.5 times ULN; ? Urea/blood urea nitrogen (BUN) and creatinine (Cr) =1.5×ULN (and creatinine clearance (CCr) = 50mL/min); ? Left ventricular ejection fraction (LVEF) =50%; QT interval corrected with Fridericia's method (QTcF) <470 msec. ? INR=1.5×ULN and APTT=1.5×ULN. 11. Women of childbearing age need effective contraception; 12.The compliance was good and the patients were followed up.
Exclusion criteria
Exclusion criteria: 1. Inability to adhere to the study protocol or study procedures; 2. Prior treatment with a VEGFR inhibitor; 3. Known HER-2 positive patients; 4. Received live vaccine within 4 weeks before enrollment or possibly during the study period; 5. Patients with other malignant tumors within 5 years before enrollment, except basal cell or squamous cell carcinoma of the skin after radical operation, or cervical carcinoma in situ; 6. Patients with active autoimmune disease or a history of autoimmune disease within 4 weeks before enrollment; 7. Previous allogeneic bone marrow transplantation or organ transplantation; 8. Severe cardiovascular disease including unstable angina or myocardial infarction within 6 months before enrollment; 9. Subjects allergic to the study drug or any of its adjuvants; 10. Distant metastasis at any site; 11. Participated in clinical trials of other drugs not yet approved or marketed in China and received treatment with corresponding trial drugs within 4 weeks before enrollment; 12. Electrolyte abnormalities judged by the investigator to be clinically significant; 13. Drug-uncontrolled hypertension was defined as systolic blood pressure =150 mmHg and/or diastolic blood pressure =90 mmHg; 14. Have any diseases or conditions that affect drug absorption before enrollment, or patients cannot take drugs orally; 15. Patients with active gastric and duodenal ulcer, ulcerative colitis or other gastrointestinal diseases or unresected tumor with active bleeding before enrollment, or other conditions that may cause gastrointestinal bleeding or perforation according to the investigator; 16. Patients with evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding >30 mL within 3 months with hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 17. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure with New York Heart Association (NYHA) grade >2; Ventricular arrhythmias requiring medical therapy; LVEF (left ventricular ejection fraction) 1×104 copies /mL or >2000 IU/ml); Known hepatitis C virus (HCV) infection and HCV RNA positive (>1×103 copies /mL); 20. Unmitigated toxic effects of grade 1 or higher above CTCAE v5.0 due to any previous anticancer therapy, excluding grade 2 or lower neurotoxicity due to alopecia, lymphopenia, and oxaliplatin; 21. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 22. Received blood transfusion, blood products, and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment; 23. Any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality where there is reason to suspect that the patient has a disease or condition (e.g., having seizures requiring treatment) that would be in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;ORR;DFS; | — |
Countries
China
Contacts
Public ContactLi Guang
Linyi People's Hospital
Outcome results
None listed