NCT02489890

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: The First People's Hospital of Changzhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Cytokine-induced Killer Cells	chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment

Timeline

• Start date: 2016-02-01
• Primary completion: 2025-07-01
• Completion: 2030-07-01
• First posted: 2015-07-03
• Last updated: 2016-02-22