D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)

Lung Cancer Clinical Trial

Official title:

Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02651441
• Other study ID #: HYK-NSCLC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 5, 2016
• Last updated: May 23, 2016
• Start date: February 2016
• Est. completion date: August 2019

Study information

• Verified date: January 2016
• Source: Shenzhen Hornetcorn Bio-technology Company, LTD
• Contact: Guang P Wang, Physician
• Phone: +86 13810661960
• Email: WangGP[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).

Description:

60 patients with stage Ⅲb～Ⅳ NSCLC will be randomly divided into group A（receive D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The patient who have singed the informed consent;

• Histologically confirmed with NSCLC at stage ?b~?;

• Expected survival time is more than 2 month;

• Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion Criteria:

• Hemoglobin<8.0 g/dL,White blood cell <3 x 10^9/L;Platelet count <75 x 10^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times;

• Known or suspected allergy to the investigational agent or any agent given in association with this trial;

• Pregnant or lactating patients;

• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;

• Patients who are suffering from serious autoimmune disease;

• Patients who had used long time or are using immunosuppressant;

• Patients who had active infection;

• Patients who are suffering from serious organ dysfunction;

• Patients who are suffering from other cancer;

• Other situations that the researchers considered unsuitable for this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Gemcitabine
Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.
• Cisplatin
Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.

Biological:
• D-CIK
8×10^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.

Locations

Country	Name	City	State
China	Affiliated Tumor Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD	Affiliated Tumor Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival		3 years	No
Secondary	Overall survival		3 years	No
Secondary	Quality of life (QOL)	The assessment will be performed using The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30).	3 years	No
Secondary	Phenotypic analysis of T cells	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell	1 year	No
Secondary	Severity of adverse events	According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)	1 year	Yes