Stomach Neoplasms
Conditions
Keywords
CIK, gastric cancer, Apatinib
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.
Detailed description
400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .
Interventions
BIOLOGICALCytokine-Induced Killer Cells
Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.
DRUGApatinib
Advanced gastric cancer patients take Apatinib 850mg qd by mouth.
Sponsors
The First People's Hospital of Changzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who can accept curative operations 18-70 years old * Histologically confirmed with gastric cancer at stage Ⅳ * Patients who can accept oral drugs; * Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
Exclusion criteria
* Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times * Known or suspected allergy to the investigational agent or any agent given in association with this trial * Pregnant or lactating patients * Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection * Patients who are suffering from serious autoimmune disease * Patients who had used long time or are using immunosuppressant * Patients who had active infection * Patients who are suffering from serious organ dysfunction * Patients who are suffering from other cancer * Other situations that the researchers considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival | 3 months |
Other
| Measure | Time frame |
|---|---|
| Adverse events | 1 months |
Outcome results
None listed