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Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215837
Recruitment Status : Unknown
Verified November 2015 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : May 24, 2016
Sponsor:
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Jingzhou Central Hospital
Information provided by (Responsible Party):
Shenzhen Hornetcorn Bio-technology Company, LTD

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE August 13, 2014
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
Progress-free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • Overall survival [ Time Frame: 3 years ]
  • Quality of life (QOL) [ Time Frame: 3 years ]
  • Phenotypic analysis of T cells [ Time Frame: 1 years ]
    The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
  • Severity of adverse events [ Time Frame: 1 years ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer
Official Title  ICMJE Randomized,Controlled,Multicenter Study of Autologous Tumor Lysate-pulsed Dendritic and Cytokine-induced Killer Cells(Ag-D-CIK) Combined With Chemotherapy for Gastric Cancer.
Brief Summary The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK) for gastric cancer.
Detailed Description 40 patients with stage Ⅰ~Ⅲ Gastric Cancer,who had received surgery and kept their tumor tissue,will be randomly divided into group A(receive Ag-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 Ag-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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Diseases
Intervention  ICMJE
  • Drug: Chemotherapy
    Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.
    Other Name: FOLFOX
  • Biological: Ag-D-CIK
    8×10^9 autologous tumor lysate pulsed 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.
Study Arms  ICMJE
  • Sham Comparator: Chemotherapy
    After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.
    Intervention: Drug: Chemotherapy
  • Experimental: Ag-D-CIK
    After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.
    Interventions:
    • Drug: Chemotherapy
    • Biological: Ag-D-CIK
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 12, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who can accept curative operations
  • 18~80 years old
  • Histologically confirmed with gastric cancer at stage Ⅰ~Ⅲ
  • Patients who can accept radical gastrectomy;
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02215837
Other Study ID Numbers  ICMJE HYK-Gastric Cancer
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shenzhen Hornetcorn Bio-technology Company, LTD
Study Sponsor  ICMJE Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators  ICMJE
  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Jingzhou Central Hospital
Investigators  ICMJE
Principal Investigator: Hai Y Liu, Professor Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center
PRS Account Shenzhen Hornetcorn Bio-technology Company, LTD
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP