advanced gastric cancer
Conditions
Interventions
treatment group:Xiakucao Xiaoliu mixure+DCF
control group: placebo+DCF
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Meet diagnostic criteria and patients was diagnosed with advanced gastric cancer; 2) men or women aged 18 to 80 years; 3) Karnofsky Performance Status scores=70; 4) Expected survival time more than 3 months; 5) According to RECIST standard, at least one diameter accurately measurable lesion, the longest diameter check with traditional technology=20mm or spiral CT=10mm; 6) Normal hematopoietic, heart, liver, kidney function: hemoglobin 90g/L, ANC 2*10^9/L, PLT10*10^9/L, total bilirubin1. 5*upper limit of normal value, AST/ALT 2.5*upper limit of normal value,AKP5.0upper limit of normal value. For hepatic metastasis patients, AST/ALT*5upper limit of normal value; 7) Initial imaging examination was finished within 14 days of the first use of the medicine. Initial clinical assessment, biochemical examination was finished within 7 days of the first use of the medicine,including routine blood test, liver and kidney function, CEA, CA-199, ECG and initial imaging examination; 8) Patients is diagnosed with advanced gastric cancer without first-line chemotherapy. If surgery, adjuvant chemotherapy is feasible postoperation; 9) Patients is informed consent and willing to follow up.
Exclusion criteria
Exclusion criteria: 1) Does not meet any one of the inclusion criteria; 2) Combined with other serious diseases, liver and renal function damage; 3) Patients with other concurrent malignancy; 4) The history of allergy to the category of paclitaxel, platinum or fluorouracil preparation; 5) Patient had previously received paclitaxel, platinum agents chemotherapy; 6) There are serious complications, such as active gastrointestinal bleeding, gastrointestinal perforation, obstruction, jaundice, non cancerous fever >38?; 7) Patients with pregnancy or lactation, childbearing age patients (male / female) who did not take appropriate contraceptive measures; 8) Patient is known to have brain or leptomeningeal metastasis; 9) Participants thought previous or current physical or mental condition of the patient may risk in the process of test, interference test evaluation or interfere with the patients to participate in the test; 10) In severe and difficult to control the local or systemic acute, chronic infection period; 11) Patients participated in clinical medicine or instrument experimental research within 30 days; 12) Patient use any other anti-cancer trial medicines at the same time or within 4 weeks; 13) The researchers considered unfit for test of the other situations: coronary heart disease and abnormal ECG; before entering the study myocardial infarction within 6 months; a history of major neurological or psychiatric disorders, including Dementia or epilepsy; activity of coagulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recent curative effect after 2 cycles of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| survival time; | — |
Countries
China
Contacts
Public ContactKeqi Han
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Outcome results
None listed