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

Phase 1

• Conditions: Lung Cancer; Non-small Cell Lung Cancer
• Interventions: Drug: Gemcitabine; Drug: Cisplatin; Biological: D-CIK

• Registration Number: NCT02651441
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

Brief 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).

Detailed 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).

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Study Start: 2016-02
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24
• Primary Completion: 2019-05
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The patient who have singed the informed consent;
• Histologically confirmed with NSCLC at stage Ⅲb～Ⅳ;
• Expected survival time is more than 2 month;
• Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-CIK	Cisplatin	After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
D-CIK	D-CIK	After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
D-CIK	Gemcitabine	After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
Chemotherapy	Gemcitabine	After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
Chemotherapy	Cisplatin	After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.

Primary Outcome Measures

Name	Time	Method
Progress-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Quality of life (QOL)	3 years	The assessment will be performed using The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30).
Phenotypic analysis of T cells	1 year	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Severity of adverse events	1 year	According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Overall survival	3 years

Trial Locations

Locations (1)

Affiliated Tumor Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China