Advanced Gastric cancer
Conditions
Interventions
experimental group versus control group:HSYW+SOX versus SOX
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Chinese Traditional Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. From 18 to 75 years old, and gender is not restricted. 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, metastatic gastric cancer or local lesions which cannot be radically removed. 3. Eastern Cancer Cooperative Group(ECOG)physical condition score(PS)0~2. 4. Life span is expected to exceed 3 months; 5. Should pass the laboratory testing data within 7 days before screening (including 7 days): Neutrophil count=1.5×10^9/L; Platelet count=90×10^9/L; Hemoglobin=90g/L (No blood transfusion within 14 days); Serum total bilirubin=1.25 times normal upper limit; ALT and AST=2.5 x ULN(Patients with liver metastases=5xULN);Serum creatinine=1.0 x ULN and creatinine clearance=60ml/minEchocardiography examination of left ventricular ejection fraction> 55%; 6. At least 1 measurable lesion outside the stomach (RECIST 1.1 Standard); 7. The subjects (or their legal agents/guardians) must sign the informed consent, indicating that they understand the purpose of this study, the necessary procedures for the research and are willing to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Patient who had chemotherapy for advanced gastric cancer, with the exception of adjuvant therapy more than 6 months before the study. 2. Patient who had any experimental drugs or antineoplastic drugs 4 weeks before enrollment . 3. Patient who had unrecovered adverse reactions caused by the previous treatment above I degree(except for hair loss); 4. Patient who had HER2 + (HER2 IHC 3+ or IHC 2+ and FISH+) and were going to take Herceptin as first-line medication. 5. Patient who had cancer history over the past five years, with the exception of those who had cured cervical or cutaneous basal cell carcinoma; Patient who had symptomatic brain or meningeal metastases (with the exception of those who was treated for more than 6 months, his or her imaging results were negative within four weeks before the study, as well as the clinical symptoms associated with the tumor were stable at enrollment) 6. Patient who had active bleeding with clinical meaning. 7. Patient who had radiotherapy treatment in his or her target lesion. 8. Patient who were pregnant or breastfeeding as well as those who are fertile but dont have adequate contraception measures; 9. Patient who had addiction of alcohol or drug; 10. Patient who had several factors affecting oral medication, such as dysphagia, chronic diarrhea, complete intestinal obstruction, etc. 11. Patient who had failure of significant organs or other serious diseases, including clinically related coronary artery disease, cardiovascular disease Patient who had myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion or unstable arrhythmia within 6 months before enrollment; 12. Patient who had serious neurological or psychiatric history; serious infection; active disseminated intravascular coagulation (DIC) or other serious diseases which could endanger patients safety or affect the completion of the study according to the judgment of researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR;QoL; | — |
Countries
China
Contacts
Public ContactShengquan Fang
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Chinese Traditional Medicine
Outcome results
None listed