Small- Cell Lung Cancer Clinical Trial
Official title:
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
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.
| Status | Active, not recruiting |
| Enrollment | 30 |
| Est. completion date | November 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Affiliated Hospital to Academy of Military Medical Sciences |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | objective rate response (CR+PR) as measured by RECIST criteria | 4 weeks after DC/CIK treatment] | No | |
| Secondary | number of participants with adverse events | 3 days within DC/CIK treatment | Yes |