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DC Vaccine Combined With CIK Cells in Patients With SCLC

Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Extensive-Stage Small- Cell Lung Cancer: a Phase I/II Study

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02688673
Enrollment
30
Registered
2016-02-23
Start date
2014-08-31
Completion date
2016-11-30
Last updated
2016-02-23

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

Conditions

Small- Cell Lung Cancer

Brief summary

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.

Interventions

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
objective rate response (CR+PR) as measured by RECIST criteria4 weeks after DC/CIK treatment]

Secondary

MeasureTime frame
number of participants with adverse events3 days within DC/CIK treatment

Outcome results

None listed

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