DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

Phase 1

• Conditions: Esophagus Cancer
• Interventions: Biological: adenovirus-transfected autologous DC vaccine plus CIK cells

• Registration Number: NCT02693236
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Status Verified: 2015-10
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Study First Posted: 2016-02-26
• Last Update Posted: 2016-02-26
• Primary Completion: 2016-08
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adenovirus-transfected autologous DC vaccine plus CIK cells	adenovirus-transfected autologous DC vaccine plus CIK cells	-

Primary Outcome Measures

Name	Time	Method
objective rate response (CR+PR) as measured by RECIST criteria	Time Frame: 4 weeks after DC/CIK treatment

Secondary Outcome Measures

Name	Time	Method
number of participants with adverse events	Time Frame: 3 days within DC/CIK treatment

Trial Locations

Locations (1)

Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, China