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CIK in Treating Patients With Bladder Cancer | Clinical Trials | Clareo Health

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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

NCT02489890•The First People's Hospital of Changzhou

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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);
+2 more criteria

Key Dates

Start Date

February 1, 2016

Primary Completion Date

July 1, 2025

Completion Date

July 1, 2030

Last Updated

February 22, 2016

Enrollment

1,500

ESTIMATED participants

Conditions

Urinary Bladder Neoplasms

Interventions

Cytokine-induced Killer Cells

BIOLOGICAL

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

NCT07222488

Bladder CancerUrinary Bladder Neoplasms

View study

RECRUITINGPHASE1

FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

NCT05614739

Urinary Bladder NeoplasmsNeoplasm Metastasis+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CIK in Treating Patients With Bladder Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer

Prognostic Performance of a Chemogram in Patients With Bladder Cancer.

A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)