DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 26, 2016
October 1, 2015
2 years
February 23, 2016
February 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
objective rate response (CR+PR) as measured by RECIST criteria
Time Frame: 4 weeks after DC/CIK treatment
Secondary Outcomes (1)
number of participants with adverse events
Time Frame: 3 days within DC/CIK treatment
Study Arms (1)
adenovirus-transfected autologous DC vaccine plus CIK cells
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2016
First Posted
February 26, 2016
Study Start
August 1, 2014
Primary Completion
August 1, 2016
Study Completion
November 1, 2016
Last Updated
February 26, 2016
Record last verified: 2015-10
Data Sharing
- IPD Sharing
- Will share