This trial is active, not recruiting.

Condition urinary bladder neoplasms
Treatment cytokine-induced killer cells
Phase phase 2
Sponsor The First People's Hospital of Changzhou
Start date February 2016
End date July 2025
Trial size 1500 participants
Trial identifier NCT02489890, BLAD001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
After accepting chemotherapy, patients will regularly follow up.
After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year.
cytokine-induced killer cells CIK
chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment

Primary Outcomes

progression-free survival(PFS)
time frame: 1 month

Secondary Outcomes

overall survival(OS)
time frame: 1 month

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Urinary Bladder Carcinoma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The First People's Hospital of Changzhou.