CIK in Treating Patients With Bladder Cancer
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 01/31/2016 |
| Prvo podneseno: | 06/23/2015 |
| Predviđena prijava poslana: | 06/30/2015 |
| Prvo objavljeno: | 07/02/2015 |
| Posljednje ažuriranje poslano: | 02/17/2016 |
| Posljednje ažuriranje objavljeno: | 02/21/2016 |
| Stvarni datum početka studija: | 01/31/2016 |
| Procijenjeni datum primarnog završetka: | 06/30/2025 |
| Procijenjeni datum završetka studije: | 06/30/2030 |
Stanje ili bolest
Intervencija / liječenje
Biological: CIK
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| No Intervention: Non-CIK After accepting chemotherapy, patients will regularly follow up. | |
| Experimental: CIK After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year. | Biological: CIK chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | Inclusion Criteria: - Patients histologically confirmed carcinoma in of the bladder with urinary cytology; - Patients with staging I-III of Bladder Cancer; - Patients who had completed chemotherapy; - Patients who have a life expectancy of at least 12 weeks; - Eastern Cooperative Oncology Group (ECOG) performance status was 0-1; - The bone marrow functioned normally (WBC>4.0×10^9/L, Hb>120 g/L, Platelet(PLT)>100×10^9/L); - The ECG results were normal, and the liver and kidney were functional. Exclusion Criteria: - Patients who had upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risk; - Patients who had urethral strictures that would prevent endoscopic procedures and repeated catheterization; - Patients who had prior or concurrent upper urinary tract tumors; - Patients who had distant metastases by imaging studies; - Patients with uncontrolled infection; underlying disease that was severe or life-threatening; - Patients who were lactating; - ECOG perform status ≥ 2; - Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment; - Patients who are pregnant or nursing; - Patients with active tuberculosis (highly positive skin tests allowed if no active disease); - Patients with disease that would preclude general anesthesia; - Patients with active intractable or uncontrollable infection. |
Ishod
Primarne mjere ishoda
1. progression-free survival(PFS) [1 month]
Sekundarne mjere ishoda
1. overall survival(OS) [1 month]
Ostale mjere ishoda
1. age [1 week]
2. gender [1 week]
3. Performance status [1 week]
4. number of sites of extranodal involvement [1 week]
5. Stage at diagnosis [1 week]
