Stomach cancer
Conditions
Interventions
Experimental group:LBP combined with capecitabine
control group:Oxaliplatin combined with capecitabine
Sponsors
The first hospital of China medical university
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old, male or female; 2. confirmed by histopathology or cytology for gastric cancer (including gastric and esophageal cancer combined with cancer); 3. clinical stage IIIA-IV gastric cancer patients; 4. First-line chemotherapy, if the patient has received neoadjuvant chemotherapy or adjuvant chemotherapy, the end of chemotherapy time is = 6 months from the time of enrollment in this study; 5. No palliative chemotherapy or molecular targeted therapy for gastric cancer (including monoclonal antibodies or small molecule tyrosine; Kinase inhibitor); 6. Patients who have received radiotherapy in the past may be enrolled in the group, but must meet the following conditions: (1) The main target lesions have not undergone radiotherapy or post-radiation therapy; (2) The toxicity caused by previous radiotherapy has been restored = CTCAE level 1; (3) The end time of radiotherapy was enrolled in this study for = 4 weeks. 7. There must be at least one measurable lesion (according to RECIST version 1.1); 8, physical condition ECOG PS: 0-1; 9. The expected survival time is = 3 months; 10. Laboratory tests meet the following criteria: Bone marrow function: absolute count of blood neutrophils (ANC) =1.5×10^9/L; platelet (PLT)=80×10^9/L; Hemoglobin (HB) = 90g / L (no blood transfusion within 2 weeks); Liver function: serum total bilirubin (TBIL), direct bilirubin (DBIL) = normal upper limit (ULN) × 1.5; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) = ULN × 2.5 (in the absence of liver metastases)(in the case of); or = ULN × 5 (with liver metastases); Kidney function: serum creatinine (Cr) = ULN; endogenous creatinine clearance (Ccr) = 55ml/min (Apply Cockcroft-Gault Formula Calculation); 11. Contraception during the study period and within 6 months after treatment, non-lactation period; 12. The patient volunteered and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. previous history of allergies to platinum compounds; 2. Combine serious cardiovascular disease, including hypertension with uncontrollable medical treatment (BP = 160/95mmHg), instability angina, history of myocardial infarction in the past June, congestive heart failure>NYHA class II, severe arrhythmia; Often pericardial effusion, etc.; 3. with severe ADH abnormal secretion syndrome, poorly controlled diabetes: daily need for more than 40 units of islets. Continued to be administered; or within 40 units of insulin per day, continuous or unused, but fasting blood glucose is still 14; More than mmol/L and 9.0% or more of HbA1c; 4. Long-term use of anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like for more than 6 months, but not Including the use of small doses of warfarin (=1mg / day) or aspirin (= 100mg / day) for prevention purposes; 5. Major surgery was performed within 4 weeks before enrollment, or the surgical wound has not completely healed; 6. The toxicity caused by previous anti-tumor therapy is still = CTCAE 2; 7. Clinical symptoms and signs When brain metastases are suspected, head MRI examinations should be performed. If brain metastases are found, they cannot be enrolled in the group; 8. Malignant tumors of other histological origins in the past 5 years, but fully treated cervix in situ carcinoma and subcutaneous lining Except cell or squamous cell carcinoma; 9. In the 4 weeks prior to enrollment, = CTCAE grade 2 hemorrhage occurred; 10. Participated in clinical trials of any research drug within 4 weeks before enrollment; 11. Severe infection within 1 week before study initiation requires intravenous antibiotics, anti-fungal or anti-viral therapy; 12. suffering from severe mental illness, poor compliance; 13. Cases that the researcher considers inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactYunpeng Liu
the First Affiliated Hospital of China Medical University
Outcome results
None listed