DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Esophagus Cancer

Treatments

Biological: adenovirus-transfected autologous DC vaccine plus CIK cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02693236

307-CTC-DC/CIK-EC

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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)