CIK in Treating Patients With 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.

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.