DC Vaccine Combined With CIK Cells in Patients With SCLC

Affiliated Hospital to Academy of Military Medical Sciences30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small- Cell Lung Cancer

Interventions

adenovirus-transfected autologous DC vaccine plus CIK cellsBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

objective rate response (CR+PR) as measured by RECIST criteria

Time frame: 4 weeks after DC/CIK treatment]

Secondary Outcomes

number of participants with adverse events

Time frame: 3 days within DC/CIK treatment

Data from ClinicalTrials.gov

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