Back to resultsDC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
Primary Purpose
Esophagus Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
adenovirus-transfected autologous DC vaccine plus CIK cells
Sponsored by
About this trial
This is an interventional treatment trial for Esophagus Cancer
Eligibility Criteria
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)
Sites / Locations
- Affiliated Hospital to Academy of Military Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adenovirus-transfected autologous DC vaccine plus CIK cells
Arm Description
Outcomes
Primary Outcome Measures
objective rate response (CR+PR) as measured by RECIST criteria
Secondary Outcome Measures
number of participants with adverse events
Full Information
NCT ID
NCT02693236
First Posted
February 23, 2016
Last Updated
February 23, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02693236
Brief Title
DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
Official Title
Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adenovirus-transfected autologous DC vaccine plus CIK cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
adenovirus-transfected autologous DC vaccine plus CIK cells
Primary Outcome Measure Information:
Title
objective rate response (CR+PR) as measured by RECIST criteria
Time Frame
Time Frame: 4 weeks after DC/CIK treatment
Secondary Outcome Measure Information:
Title
number of participants with adverse events
Time Frame
Time Frame: 3 days within DC/CIK treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
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