DC Vaccine Combined With CIK Cells in Patients With SCLC

A

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Small- Cell Lung Cancer

Treatments

Biological: adenovirus-transfected autologous DC vaccine plus CIK cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02688673
307-DC/CIK-SCLC

Details and patient eligibility

About

The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously preclinical research with DC combined with CIK cells, the investigators 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 Small- Cell Lung 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

  • Clinically relevant diseases or infections (HBV, HCV, HIV)
  • Females who are pregnant or nursing
  • Immunosuppressant treatment
  • Currently participating in another clinical trial
  • Unfit for participating in this clinical trial in investigators' opinions

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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