NCT02489890Active, not recruitingPhase 2
CIK in Treating Patients With Bladder Cancer
A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Urinary Bladder Carcinoma
Source: ClinicalTrials.gov · Last updated 22 Feb 2016
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 24 Jun 2015
- Start date
- Feb 2016
- Primary completion date
- Jul 2025
- Lead sponsor
- The First People's Hospital of Changzhou
- Diseases
- Bladder cancer
- NCT number
- NCT02489890
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 1500
- From Feb 2016 to the primary completion date, Jul 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who had prior or concurrent upper urinary tract tumors;
Other illness
- Patients who had upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risk;
- Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
- 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.
Other
- Patients who had urethral strictures that would prevent endoscopic procedures and repeated catheterization;
- Patients who had distant metastases by imaging studies;
- Patients who were lactating;
- ECOG perform status ≥ 2;
- Patients who are pregnant or nursing;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.