Urinary Bladder NeoplasmsPhase 2NCT02489890
CIK in Treating Patients With Bladder Cancer
A Phase 2 study testing Cytokine-induced Killer Cells in people with Urinary Bladder Neoplasms, run by The First People's Hospital of Changzhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Cytokine-induced Killer Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Urinary Bladder Carcinoma
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.
Read the 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.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Cytokine-induced Killer Cells
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine-induced Killer CellsBiological
Also called CIK
chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment
| Study group | Role | What they receive |
|---|---|---|
| Non-CIK | No intervention | After accepting chemotherapy, patients will regularly follow up. |
| CIK | Experimental | After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year. Receives: Biological: Cytokine-induced Killer Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival(PFS)
Measured: 1 month
Secondary outcomes (1)
overall survival(OS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionJul 2025 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489890
- Sponsor's protocol ID
- BLAD001
- Status last verified
- Feb 2016
- First submitted
- 24 Jun 2015
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Urinary Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT02489890
- Acronym / sponsor ID
- BLAD001
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-CIK | No intervention | –After accepting chemotherapy, patients will regularly follow up. |
| CIK | Experimental | Biological: Cytokine-induced Killer CellsAfter accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytokine-induced Killer CellsAlso: CIKchemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment | Biological | CIK |
Primary outcome
progression-free survival(PFS)
Time frame: 1 month
1 secondary outcome
overall survival(OS)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytokine-induced Killer Cells in people with Urinary Bladder Neoplasms, run by The First People's Hospital of Changzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival(PFS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.