DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

NCT ID: NCT02693236

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Esophagus Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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adenovirus-transfected autologous DC vaccine plus CIK cells

Group Type EXPERIMENTAL

adenovirus-transfected autologous DC vaccine plus CIK cells

Intervention Type BIOLOGICAL

Interventions

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adenovirus-transfected autologous DC vaccine plus CIK cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Hospital to Academy of Military Medical Sciences

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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307-CTC-DC/CIK-EC

Identifier Type: -

Identifier Source: org_study_id

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