gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and more; 2. ECOG physical status 0-1; 3. The histologic diagnosis of stomach / gastroesophageal junction adenocarcinoma; 4. According to the RECIST 1.1 standard with measurable or evaluable lesions; 5. Accept swallow oral drug; 6. WBC=4.0*10^9/L; ALC=0.8*10^9/L; ANC=1.5*10^9/L; PLT=100*10^9/L; ALT, AST=2.5 times of the normal limit; ALP=2.5 times of the normal limit; TBIL<1.5 times of the normal limit; SCr<1 times of the normal limit; ALB=30g/L; 7. The expected survival time of more than 3 months; 8. good compliance; 9. provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Vital organs (heart, liver, kidney) function is serious dysfunction; 2. Patients received organ transplantation; 3. Patients with other malignant tumors or have occurred brain metastasis; 4. Patients with history of autoimmune disease; 5. Patients in pregnancy or breast-feeding period (women of child-bearing age need to check pregnancy test); 6. Patients with acute infection disease or in chronic active stage; 7. Patients with clear history of drug allergy or belong to allergic constitution; 8. Patients received chemotherapy, radiation therapy, immunosuppressive drugs (cyclosporine A, etc.) or other immune treatment in 4 weeks; 9. Patients received other clinical trials in 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;overall survival;median survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The disease control rate;Objective remission rate;molecular markers in serum;subsets of lymphocytes in PBMC;regulator T cell in PBMC;suppressor T cell in PBMC; | — |
Countries
China
Contacts
Cancer Institute and Hospital, Chinese Academy of Medical Sciences