DC Vaccine Combined With CIK Cells in Patients With SCLC

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)