The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
This trial is active, not recruiting.
|Treatment||cytokine-induced killer cells|
|Sponsor||The First People's Hospital of Changzhou|
|Start date||July 2015|
|End date||July 2043|
|Trial size||1200 participants|
|Trial identifier||NCT02487992, CZYY-CRC-001|
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.
|Intervention model||parallel assignment|
time frame: 3 months
time frame: 3 months
Male or female participants from 18 years up to 75 years old.
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.
|Official title||The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer|
|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) .|
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