DC Vaccine Combined With CIK Cells in Patients With SCLC
Phase 1
- Conditions
- Small- Cell Lung Cancer
- Registration Number
- NCT02688673
- Lead Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method objective rate response (CR+PR) as measured by RECIST criteria 4 weeks after DC/CIK treatment]
- Secondary Outcome Measures
Name Time Method number of participants with adverse events 3 days within DC/CIK treatment