Clinical trial NCT02489890: CIK in Treating Patients With Bladder Cancer
Official title: A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Urinary Bladder Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Urinary Bladder Neoplasms
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival(PFS)
timeFrame: 1 month
Secondary outcomes:
measure: overall survival(OS)
timeFrame: 1 month
Other outcomes:
measure: age
timeFrame: 1 week
measure: gender
timeFrame: 1 week
measure: Performance status
timeFrame: 1 week
measure: number of sites of extranodal involvement
timeFrame: 1 week
measure: Stage at diagnosis
timeFrame: 1 week
Locations:
Study officials:
References: