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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02693236

Enrollment

Registered

2016-02-26

Start date

2014-08-31

Completion date

2016-11-30

Last updated

2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer

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.

Interventions

BIOLOGICALadenovirus-transfected autologous DC vaccine plus CIK cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026