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Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder Cancer.
About 1500 patients with staging I-III of Bladder Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-CIK | No Intervention | After accepting chemotherapy, patients will regularly follow up. | |
| CIK | Experimental | After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytokine-induced Killer Cells | Biological | chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival(PFS) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| age | by years | 1 week |
| gender | men or women | 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Performance status |
WHO standard |
| 1 week |
| number of sites of extranodal involvement | evaluated by CT scan | 1 week |
| Stage at diagnosis | Tumor Node Metastasis (TNM) stage, Tumor:CIS,T1,T2,T3,T4 according to the depth of tumor invasion. Lymph node involvement: N0,N1,N2. Metastasis: M0,M1 | 1 week |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |