Gastric Cancer
Conditions
Interventions
experimental group:Fruquintinib combined with S-1 and oxaliplatin
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~75 years old, male or females; 2. ECOG(Eastern Cooperative Oncology Group) 0~2; 3. Definitely diagnosed gastric adenocarcinoma through Pathology or Cytology with Her2-negative; 4. Imaging evaluation or exploration during planned radical surgery for gastric cancer reveal that radical resection (D2 + R0) can not be performed, followed at least one of the criteria below: (1) Tumors invade duodenum, pancreas, mesenteric root and/or hepatoduodenal ligament,radical surgery can not be performed; (2) Para-aortic lymph node enlargement(> 1cm); (3) Multiple perigastric lymph nodes enlargement or main perigastric blood vessels surrounded by fused lymph nodes, D2 lymph node dissection can not be performed; 5. Expected lifetime acuity >=3 months; 6. Without the history of anti-tumor therapy including Radiotherapy, chemotherapy, targeted therapy, immunotherapy 7. Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC>4.0x10^9/L, NE>1.5x10^9/L, PLT>100x10^9/L, BIL50ml/min using Cockcroft-Gault formula,and Cr<=1 ULN; 8. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease; 9. Not concomitant with other uncontrollable benign disease before the recruitment (e.g. the infection in the kidney, lung and liver); 10. No other clinical studies were conducted before and during the treatment; 11. Females of childbearing potential must not be lactating or pregnant at Screening or Baseline. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 7 days before the first dose of study drug. Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation; 12. Subjects volunteered to join the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females; females at childbearing age and of pregnancy desire during the study; 2. Her-2 test was positive and willing to receive Hessaitin treatment; 3. Patients with surgical treatment and chemotherapy contraindications or physical condition and organ function are not allowed to undergo large abdominal surgery; 4. History of hypertension, systolic blood pressure> 140 mmHg and/or diastolic blood pressure> 90 mmHg after medical treatment; history of coronary heart disease and/or arrhythmia greater than New York Heart Association (NYHA) Class I and/or cardiac insufficiency = Class II; 5. Coagulant function abnormality (INR > 1.5 and/or prothrombin time (PT) > ULN + 4 seconds and/or APTT > 1.5 ULN), bleeding tendency undergoing thrombolytic and anticoagulant therapy; 6. Urinary protein positive patients (urinary protein detection 2 + or more, or 24-hour urinary protein quantification > 1.0g); 7. Pulmonary hemorrhage (> CTCAE 2) occurred within 4 weeks before administration, and other bleeding (> CTCAE 3) occurred within 4 weeks before administration; 8. Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment 9. History of gastric surgery; 10.Allergy to the drugs in this protocol; 11. Distant metastases (cM1) exclude inclusion criterias; 12. Any medical or other condition that in the opinion of the investigator would preclude the subjects participation in a clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radical resection rate;medicine safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| excision rate after transformation therapy;ORR;pathCR+pathPR;surgical safety; | — |
Countries
China
Contacts
Public ContactLijun Zheng
Shanghai Tenth People's Hospital
Outcome results
None listed