Back to resultsCIK in Treating Patients With Bladder Cancer
Primary Purpose
Urinary Bladder Neoplasms
Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cytokine-induced Killer Cells
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non-CIK
CIK
Arm Description
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.
Outcomes
Primary Outcome Measures
progression-free survival(PFS)
Secondary Outcome Measures
overall survival(OS)
Full Information
NCT ID
NCT02489890
First Posted
June 24, 2015
Last Updated
February 18, 2016
Sponsor
The First People's Hospital of Changzhou
1. Study Identification
Unique Protocol Identification Number
NCT02489890
Brief Title
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
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First People's Hospital of Changzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-CIK
Arm Type
No Intervention
Arm Description
After accepting chemotherapy, patients will regularly follow up.
Arm Title
CIK
Arm Type
Experimental
Arm Description
After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year.
Intervention Type
Biological
Intervention Name(s)
Cytokine-induced Killer Cells
Other Intervention Name(s)
CIK
Intervention Description
chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment
Primary Outcome Measure Information:
Title
progression-free survival(PFS)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
overall survival(OS)
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
age
Description
by years
Time Frame
1 week
Title
gender
Description
men or women
Time Frame
1 week
Title
Performance status
Description
WHO standard
Time Frame
1 week
Title
number of sites of extranodal involvement
Description
evaluated by CT scan
Time Frame
1 week
Title
Stage at diagnosis
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
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CIK in Treating Patients With Bladder Cancer
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