Gastric Cancer
Conditions
Interventions
Control group:chemotherapy
Sponsors
Jiangsu Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathological diagnosis of gastric cancer; 2. Patients with histologically or cytologically confirmed stage III after resection or IV,who cannot undergo radical surgery or postoperative recurrence and metastasis; 3. KPS scores >60; 4. Aged from 18 to 75 years old; 5. Patients with life expectancy of at least 6 months; 6. Patients who provide written informed conset to participate in the study according to the GCP criteria; 7. Childbearing age women whose urine pregnancy test is negative within 7 days before enrollment. All the patients and their spouse should abstinence all the time or at fixed periods during this trail or take at least 2 effective contraceptives. Abstinence or contraceptives still need to be used for 2 years after the trail.
Exclusion criteria
Exclusion criteria: 1. Patients who is unable to swallow oral medications(including with digestive tract obstruction and jejunostomy; 2. Patients with symptomatic brain metastasis or mental disorder; 3. Patients who has severe cardiovascular disease, hepatopathy, kidney disease or blood disease; 4. Patients whose laboratory examination before enrollment is abnormal: Blood routine examination: ANC1.5 UNL, CCr1.5 UNL, ALT(SGPT) and AST(SGOT) >1.5×UNL; 5. Patients who are pregnant, nursing; 6. Patients who are substance abuse,or with clinical ,mental and social features which is interference for the study and informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year survival rate;progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective remission rate;tumor marker;TCM sydrome score;piper fatigue scale;immunosuppressive cell population;cytokines;Quality of life; | — |
Countries
China
Contacts
Public ContactXi Zou
Jiangsu Province Hospital of Chinese Medicine
Outcome results
None listed