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

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ClinicalTrials.gov Identifier: NCT02651441
Recruitment Status : Unknown
Verified January 2016 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Recruiting
First Posted : January 11, 2016
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Lung Cancer Non-small Cell Lung Cancer Drug: Gemcitabine Drug: Cisplatin Biological: D-CIK Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer
Study Start Date : February 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: D-CIK
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines,patients will receive 3 cycles of D-CIK treatment.
Drug: Gemcitabine
Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.
Other Name: Gemzar

Drug: Cisplatin
Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
Other Name: cisplatinum

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.

Active Comparator: Chemotherapy
After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up.
Drug: Gemcitabine
Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.
Other Name: Gemzar

Drug: Cisplatin
Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
Other Name: cisplatinum




Primary Outcome Measures :
  1. Progress-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Quality of life (QOL) [ Time Frame: 3 years ]
    The assessment will be performed using The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-QLQ-C30).

  3. Phenotypic analysis of T cells [ Time Frame: 1 year ]
    The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

  4. Severity of adverse events [ Time Frame: 1 year ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651441


Contacts
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Contact: Guang P Wang, Physician +86 13810661960 WangGP@163.com

Locations
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China, Guangdong
Affiliated Tumor Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Yuan Z Wang, Professor    020-66673666    WangZY@QQ.com   
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Investigators
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Principal Investigator: Zhi Z Zhang, Professor Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center

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Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02651441     History of Changes
Other Study ID Numbers: HYK-NSCLC
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
D-CIK
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs