Lung Cancer, Non-small Cell Lung Cancer
Conditions
Keywords
D-CIK, lung cancer
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).
Interventions
DRUGGemcitabine
Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.
DRUGCisplatin
Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
BIOLOGICALD-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.
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Shenzhen Hornetcorn Bio-technology Company, LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | — |
| 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) |
Countries
China
Contacts
Primary ContactGuang P Wang, Physician
Outcome results
None listed