DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

February 23, 2016 updated by: Affiliated Hospital to Academy of Military Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Affiliated Hospital to Academy of Military Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adenovirus-transfected autologous DC vaccine plus CIK cells
Biological: adenovirus-transfected autologous DC vaccine plus CIK cells

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-CTC-DC/CIK-EC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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