DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

Esophagus Cancer Clinical Trial

Official title:

Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02693236
• Other study ID #: 307-CTC-DC/CIK-EC
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 23, 2016
• Last updated: February 23, 2016
• Start date: August 2014
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histopathologically confirmed diagnosis of esophagus cancer

• Age >18 years at time of consent

• Received standardized treatment of Small-Cell Lung Cancer

• Interval between the last standardized treatment and DC/CIK treatment = 4weeks

• KPS (Karnofsky performance scale) >60

• Patient's written informed consent

• No severe viral or bacterial infections

• Predicted survival >3 months

Exclusion Criteria:

• Serious dysfunction of vital organs(heart, liver or kidney)

• History of autoimmune diseases

• Pregnant and breast-feeding patient

• Active or chronic infectious diseases

• History of allergy or hypersensitivity to study product excipients

• Currently participating in another clinical trial

• Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks

• Clinically relevant diseases or infections (HBV, HCV, HIV)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Biological:
• adenovirus-transfected autologous DC vaccine plus CIK cells

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective rate response (CR+PR) as measured by RECIST criteria		Time Frame: 4 weeks after DC/CIK treatment	No
Secondary	number of participants with adverse events		Time Frame: 3 days within DC/CIK treatment	Yes