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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIK plus S-1 and Bevacizumab | Experimental | Cytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. Cytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress. |
|
| S-1 and Bevacizumab | No Intervention | S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytokine-Induced Killer Cells | Biological | CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 1 months |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |