gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18~80 years, males or females; 2. Definitely diagnosed gastric adenocarcinoma or adenocarcinoma of esophagogastric junction through Pathology or Cytology; 3. 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: a. Tumors invade duodenum, pancreas, mesenteric root and/or hepatoduodenal ligament,radical surgery can not be performed. b. Para-aortic lymph node enlargement(> 1cm). c. Multiple perigastric lymph nodes enlargement or main perigastric blood vessels surrounded by fused lymph nodes, D2 lymph node dissection can not be performed. 4. ECOG(Eastern Cooperative Oncology Group) 0~2; 5. Expected lifetime acuity =3 months; 6. Adequate organ functions defined as indicated below: (1) Adequate bone marrow function, defined as:a. HB=90 g/Lb. ANC=1.5×10^9/Lc. PLT=80×10^9/L (2) Adequate liver function, defined as: TBIL45ml/min using Cockcroft-Gault formula or Cr=1.25×ULN; 7. 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. 8. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females; 2. 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; 3. Coagulant function abnormality (INR > 1.5 and/or prothrombin time (PT) > ULN + 4 seconds and/or APTT > 1.5 ULN), bleed-ing tendency undergoing thrombolytic and anticoagulant therapy; 4. Pulmonary hemorrhage (> CTCAE 2) occurred within 4 weeks before administration, and other bleeding (> CTCAE 3) occurred within 4 weeks before administration; 5. History of gastric surgery; 6. Distant metastases (cM1) exclude inclusion criterias; 7. 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 |
|---|---|
| R0 resection rate;D2 lymph node dissection rat; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;tumor regression grade; | — |
Countries
China
Contacts
Department of Gastrointestinal Surgery, People's hospital of Tongling City