Adenocarcinoma of the stomach or gastroesophageal junction
Conditions
Interventions
Experimental group:fruquintinib combined with trastuzumab and XELOX
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Aged 18-75 years (including 18 and 75 years); 3. Pathologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma; 4. Have not received anti-tumor therapy for metastatic disease before; It mainly includes systematic chemotherapy, molecular targeted therapy, immune checkpoint inhibitor therapy and so on. 5. Positive Her2; 6.ECOG physical condition 0-1 score; 7. Expected survival =3 months; 8. There must be at least one measurable lesion with a maximum diameter of at least 10mm measured by spiral CT scan and at least 20mm measured by conventional CT scan (RECIST version 1.1); 9. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within *14 days before enrollment) : Absolute neutrophil count =1.5×109/L; Platelet =100×109/L; Hemoglobin =90g/L; Total bilirubin < 1.5 ULN; ALT and/or AST < 1.5 times ULN; Serum creatinine < 1.5 ULN; Endogenous creatinine clearance =50ml/min; 10. Women of childbearing age need to take effective contraceptive measures; Good compliance, cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Failure to comply with the study protocol or study procedure; 2. Previous treatment with chemotherapy, VEGFR inhibitors or previous treatment with immune checkpoint inhibitors; 3. Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 4. There were central nervous system (CNS) metastases or previous brain metastases before enrollment; 5. Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment; 6. Previously received allogeneic bone marrow transplantation or organ transplantation; 7. Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher); 8. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment; 9. Subjects who are allergic to the investigational drug or any of its adjuncts; 10. Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment; 11. International Normalized Ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN; 12. The investigator identified clinically significant electrolyte abnormalities; 13. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 14. Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration =CTCAE level 2 after formal treatment); 15. Had any disease or condition prior to enrollment that affected drug absorption, or the patient could not take fruquintinib orally; 16. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment; 17. Patients with significant evidence or history of bleeding tendency within 3 months (bleeding >30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to enlistment; 18. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade >2; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) 1×104 copies /mL or >2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL)]; 21. Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade =2 neurotoxicity; 22. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactHuifang Lv
Henan Cancer Hospital
Outcome results
None listed