Overview

This trial is active, not recruiting.

Condition esophagus cancer
Treatment adenovirus-transfected autologous dc vaccine plus cik cells
Phase phase 1/phase 2
Sponsor Affiliated Hospital to Academy of Military Medical Sciences
Start date August 2014
End date August 2016
Trial size 30 participants
Trial identifier NCT02693236, 307-CTC-DC/CIK-EC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adenovirus-transfected autologous dc vaccine plus cik cells

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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)

Additional Information

Official title Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Affiliated Hospital to Academy of Military Medical Sciences.