Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases

Safety and Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases: a Phase I/II Study

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02688686

Enrollment

Registered

2016-02-23

Start date

2016-02-29

Completion date

Unknown

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Cancer With Bone Metastases

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.

Interventions

BIOLOGICALgenetically modified dendritic cells + cytokine-induced killer

This Phase I/II Study to evaluate clinical efficacy, safety of genetically modified dendritic cells in combination with cytokine-induced killer cell treament in NSCLC with bone metastases.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
objective response rate (CR+PR) as measured by RECIST criteria	one month after DC/CIK treatment

Secondary

Measure	Time frame
number of participants with adverse events	3 days during DC/CIK treatment]

Countries

China

Contacts

Primary ContactGuo liang ding, master

dingguoliang1999@sina.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026