Colorectal Neoplasms
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.
Detailed description
1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),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 S-1 and Bevacizumab (continuous) .
Interventions
BIOLOGICALCytokine-Induced Killer Cells
CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells.
Sponsors
The First People's Hospital of Changzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who can accept curative operations 18-70 years old * Histologically confirmed with colorectal 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