DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer

A

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

adenovirus-transfected autologous DC vaccine plus CIK cells
Experimental group
Treatment:
Biological: adenovirus-transfected autologous DC vaccine plus CIK cells

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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