Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases
Phase 1
- Conditions
- Non-Small-Cell Lung Cancer With Bone Metastases
- Registration Number
- NCT02688686
- Lead Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Brief Summary
The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously preclinical study with DC vaccine 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 non-small cell lung cancer
- Age >18 years at time of consent
- Received standardized treatment of Non-Small-Cell Lung Cancer with bone metastases
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method objective response rate (CR+PR) as measured by RECIST criteria one month after DC/CIK treatment
- Secondary Outcome Measures
Name Time Method number of participants with adverse events 3 days during DC/CIK treatment]
Trial Locations
- Locations (1)
Affiliated Hospital to Academy of Military Medical Sciences
🇨🇳Beijing, Beijing, China