CIK in Treating Patients With Bladder Cancer

Phase 2

Active, not recruiting

• Conditions: Urinary Bladder Neoplasms
• Interventions: Biological: Cytokine-induced Killer Cells

• Registration Number: NCT02489890
• Lead Sponsor: The First People's Hospital of Changzhou

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.

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Status Verified: 2016-02
• Study Start: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-22
• Primary Completion: 2025-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIK	Cytokine-induced Killer Cells	After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year.

Primary Outcome Measures

Name	Time	Method
progression-free survival(PFS)	1 month

Secondary Outcome Measures

Name	Time	Method
overall survival(OS)	1 month